Anjan Dhar - Academia.edu (original) (raw)
Papers by Anjan Dhar
On review of the patients whose cause of death were attributed to cancer, 12 did not have maligna... more On review of the patients whose cause of death were attributed to cancer, 12 did not have malignancy as initial HPN indication. Regarding mortality not linked to HPN, respiratory complications including pneumonia were the commonest causative factor (8/29, 28%). Conclusions This study showed that mortality was associated with the underlying disease condition resulting in the need for HPN or other co-morbidities rather than direct complications of HPN itself. REFERENCE 1. Pironi L, Joly F, Forbes A, et al. Long-term follow-up of patients on home parenteral nutrition in Europe: implications for intestinal transplantation. Gut 2011;60:1-5.
Gut, Jun 1, 2013
Further information on outcomes was gathered from individual consultation with patients. Results ... more Further information on outcomes was gathered from individual consultation with patients. Results 80 pregnancies in 57 patients with CD were identified.10 patients currently pregnant,9 patients(13 pregnancies) with incomplete data were excluded.Therefore,pregnancy outcomes of 57 pregnancies/38 patients (mean age: 30.7 years) were analysed. 31/38(82%) of patients had luminal disease,7/38(18%) perianal disease.36/38(95%) conceived naturally,1/38(2.5%) by assisted reproduction,1/38(2.5%) by IVF.25/57(44%) pregnancies were on no treatment in early pregnancy, 4/57(7%) on biologics [Infliximab 3/4(75%),Adalimumab1/4(25%)],6/57(10%) on biologics+t hiopurines(TPN),6/57(10%) on TPN,6/57(10%) on TPN+5-ASA,7/57(12%) on 5-ASA,2/57(3.5%) on steroids and 1/57(1.7%) on elemental diet.15/57(26%) pregnancies had flares,of which 5/15(33%) continued throughout pregnancy.5/15(33%) occurred in the 1st trimester,4/15(27%) in the 2nd, 1/15(7%) in the 3rd. Of all pregnancies with flares,9/15(60%) were on no CD therapy. The mean week of delivery was 39.5 weeks (36-42).32/46(70%) of deliveries were vaginal and 14/46(30%) by Caesarian section (CS). Of CS,8/14(57%) were planned due to perianal disease 5/8(63%) or obstetric indication 3/8(37%).Pregnancy outcomes were:live births 46/57(81%), miscarriages 10/57(17%), termination 1/57(2%). The mean birth weight (BW) of the newborns was 3 kg (1.9 kg-5.1 kg). 4/46(11%) of the babies were of low BW (<2.5kg). Neonatal issues were recorded in 5/46(11%); 1 diabetes mellitus,2 cardiac anomalies,1 with viral infection at 8 days, 1 cot death. Of the miscarriages, 5/10(50%) were on no CD therapy and 4/10(40%) flared in early pregnancy. The termination was due to use of medication unrelated to CD that could potentially cause congenital anomalies. The number of pregnancies in a specialist IBD clinic is high up to 20/year in this series highlighting a potential additional service need.A specialist obstetric medicine service can provide reassurance regarding safety of drugs in pregnancy,which in turn may reduce flare rates and result in good pregnancy outcomes. Observed outcomes did not fall outside that expected from larger reported series.
Frontline Gastroenterology, Jun 2, 2022
Eosinophilic oesophagitis is now being diagnosed more often, although there continues to be a sig... more Eosinophilic oesophagitis is now being diagnosed more often, although there continues to be a significant delay in the recognition of the condition in primary care, and among patients presenting with food bolus obstruction to other specialities like Ears, Nose and Throat and Accident & Emergency. The diagnosis requires endoscopy and biopsy, with six biopsies taken from at least two different areas of the oesophagus. The diagnostic threshold is > 15 eosinophils/high power field or 0.3 mm 2 . Dietary management although effective is often difficult to carry out due to poor adherence by patients and the need for a specialist dietitian and repeated biopsies. Orodispersible budesonide is very effective for inducing remission and maintaining it long term, with fewer biopsies. Newer targeted biological agents are promising in the treatment of patients who have not responded to conventional treatments. Dilatation of strictures in this condition is safe.
Journal of the Royal College of Physicians of Edinburgh, Dec 1, 2020
Gastrointestinal Endoscopy, Apr 1, 2012
Frontline Gastroenterology, May 25, 2023
Background and aims Healthcare quality improvement (QI) is the systematic process to continuously... more Background and aims Healthcare quality improvement (QI) is the systematic process to continuously improve the quality of care and outcomes for patients. The landmark Inflammatory Bowel Disease (IBD) UK National Audits provided a means to measure the variation in care, highlighting the need to define the standards of excellence in IBD care. Through a consensus approach, we aimed to establish key performance indicators (KPIs), providing reliable benchmarks for IBD care delivery in UK. Methods KPIs that measure critical aspects of a patient journey within an IBD service were identified though stakeholder meetings. A twostage Delphi consensus was then conducted. The first involved a multidisciplinary team of IBD clinicians and patients to refine definitions and methodology. The second stage assessed feasibility and utility of the proposed QI process by surveying gastroenterology services across UK. Results First, the four proposed KPIs were refined and included time from primary care referral to diagnosis in secondary care, time to treatment recommendation following a diagnosis, appropriate use of steroids and advanced therapies prescreening and assessment. Second, the Delphi consensus reported >85% agreement on the feasibility of local adoption of the QI process and >75% agreement on the utility of benchmarking of the KPIs. Conclusions Through a structured approach, we propose quantifiable KPIs for benchmarking to improve and reduce the individual variation in IBD care across the UK. ⇒ This British Society of Gastroenterology IBD QI initiative will focus on the performance of IBD services against defined KPIs and will complement the IBD UK benchmarking tool which assess performance against defined IBD standards via patient surveys and service self-assessments.
transcribed and analysed for IBD outcomes elicited by clinicians (or volunteered by patients), in... more transcribed and analysed for IBD outcomes elicited by clinicians (or volunteered by patients), including specific items required for Harvey-Bradshaw Index (HBI) and Simple Clinical Colitis Activity Index (SCCAI). Results Most commonly elicited outcomes are shown in the table 1. HBI or SCCAI were collected in only 4 (8%) of consultations. In the remainder, domains of HBI and SCCAI were discussed in variable detail. Complete HBI coverage: 5/29 (17%); symptom components of HBI (wellbeing, liquid stools, abdominal pain): 16/29 (55%). No Crohn's disease consultation involved specific discussions about symptoms over past 24 hrs (including 2 where HBI was calculated). Complete SCCAI coverage: only 1 consultation. Partial coverage (5 out of 6 SCCAI domains): 8/21 (38%). Symptoms were never specifically defined over past 3 days. Certain symptoms were elicited significantly more often by nurses than doctors (p<0.05), and coverage varied by disease severity. Interviews are under way to explore views, barriers and facilitators to standardisation of outcomes assessment. Conclusions There is high variability in breadth, depth and quantification of outcomes during routine clinical assessments. Most domains for activity indices were elicited but formal scoring and assessment for a fixed time period was rare. Standardised outcomes may be better-captured directly from patients (PROMs) than via clinician-generated indices.
Journal of Crohn's and Colitis, 2022
Background Vedolizumab, a gut-selective monoclonal antibody targeting α4β7-integrin, was recently... more Background Vedolizumab, a gut-selective monoclonal antibody targeting α4β7-integrin, was recently licenced as a subcutaneous (SC) preparation after demonstrating efficacy compared to placebo at maintaining remission in IBD patients who had a clinical response to intravenous (IV) induction therapy. We aimed to assess real-world experience of switching patients to SC administration. Methods Patients across 10 UK centres who had completed induction with IV vedolizumab were offered SC therapy. Demographic data and baseline disease characteristics (disease type and behaviour, medication history) were collected, alongside biochemical markers (C-reactive protein, faecal calprotectin), disease activity scores (SCCAI, partial Mayo or modified Harvey Bradshaw Index) and quality of life scores (IBD-Control-8) at baseline (defined as the first dose of SC medication), 8 and 24. Data was also collected on drug persistence, hospital admissions, steroid use and reported adverse events. Results 351 ...
Gastroenterology, 2020
BACKGROUND AIMS Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topi... more BACKGROUND AIMS Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear if these drugs are effective for long-term maintenance of remission. METHODS We performed a double-blind trial to compare the efficacy and safety of 2 doses of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histological relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n=68), BOT 1.0 mg twice daily (n=68), or placebo twice daily (n=68) for up to 48 weeks. RESULTS At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission, compared with 4.4% of patients in the placebo group (P<.001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment. CONCLUSIONS In a phase 3 trial, up to 48 weeks of treatment with BOT (.5 mg or 1.0 mg, twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. (Funded by Dr. Falk Pharma GmbH; EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.).
Gut, Jun 1, 2016
endoscopists reported hiatus hernia length in only 38% of cases, with doctor (any grade) reportin... more endoscopists reported hiatus hernia length in only 38% of cases, with doctor (any grade) reporting at 62%. Interestingly overall only 32% of reports made any mention of proton pump inhibitor (PPI) use or advised of PPI initiation. Of the total (n = 250) 7 cases of dysplasia and 4 cases of adenocarcinoma were detected. The single detected high-grade dysplasia was referred appropriately for UGI multidisciplinary team input. Two cases of indefinite dysplasia were noted, and repeat endoscopy planned within a 6 month period. The overall finding of 11 cases (4.4%) of dysplasia or malignancy was in keeping with expected detection rates as reported by recent meta-analyses.(Qiao 2015) Conclusion While dysplasia and adenocarcinoma detection rates are within acceptable ranges, improved adherence to the 'minimum dataset' is needed. We have recommended serial clinical update sessions for endoscopists and planned further re-audit.
Frontline Gastroenterology, Sep 21, 2018
Background Endoscopic antireflux radiofrequency treatment (Stretta) offers a therapeutic alternat... more Background Endoscopic antireflux radiofrequency treatment (Stretta) offers a therapeutic alternative for patients suffering from refractory gastrooesophageal reflux disease (GORD). Current evidence suggests that the treatment may improve symptoms of GORD and decrease requirement for proton pump inhibitor (PPI) therapy. Methods Prospective assessment of patients undergoing Stretta, between October 2014 and February 2016, in a UK tertiary referral centre was carried. All patients were assessed for suitability using endoscopy, contrast studies, and pH and manometry studies. The Gastrooesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) was used to evaluate symptoms along with PPI dependency, pre-Stretta and post-Stretta treatment. Patients were followed up by outpatient clinic appointment and telephone consultation. Results Fifty consecutive patients were followed up for a median of 771 days (range 499-1162) following treatment with Stretta. The average GERD-HRQL score improved from 46.2/75 (±14.2) preprocedure to 15.2/75 (±17.3) postprocedure. Dissatisfaction with GORD as measured in the GERD-HRQL decreased from 100% to 10% with three patients showing no improvement (non-responders) at follow up and two late failures at the time of this review. There were no complications and all cases were carried out as day cases.
Frontline Gastroenterology, Jul 19, 2016
Background Gastrointestinal stromal tumours (GISTs) are rare mesenchymal tumours of the gastroint... more Background Gastrointestinal stromal tumours (GISTs) are rare mesenchymal tumours of the gastrointestinal tract. We retrospectively reviewed the clinical management of all patients with GIST presenting to a regional multidisciplinary upper gastrointestinal cancer group in the north of England. Methods Clinical, pathological, immunohistochemical treatment strategies, follow-up and outcome data on all patients with GIST between 2007 and 2012 were reviewed. Tumours were categorised by risk according to the National Institutes of Health (NIH) and AFIP models. Results 36 (85.7%) of 42 tumours were located in the stomach, 5 (11.9%) in the small intestine and 1 (2.4%) in the oesophagus. Median age of patients was 68 (range 43-91) years. 24 patients (57.1%) were female. Tumour size ranged from 1.0 to 12.7 cm with mean size of 5.46 cm. Metastasis was present in 19 (45.2%) patients at diagnosis with distant metastases in 12 patients. Liver was the most common site of metastases. Histology and immunohistochemical analysis was available in 32 (76.2%) patients. Most common histology was spindle cell morphology 17/32 (53.1%) followed by epithelioid 9/32 (28.1%) and mixed morphology 5/32 (15.6%). The positive rate for KIT protein (CD117) was 90.6%, while that for CD34 was 75.0%. 12/25 (48.0%) and 8/23 (34.8%) patients were categorised as high risk as per NIH and AFIP risk scores, respectively. 23/42 (54.8%) patients underwent surgical resection, after which 5/23 (21.7%) had adjuvant imatinib therapy. Imatinib was given as primary therapy in 14/42 (33.3%) patients. Conclusions Surgery alone may not be a curative treatment for GISTs. Targeted therapy with imatinib may play an important role in the treatment of GISTs. Further risk categorisation models may be needed to evaluate GIST behaviour and prognosis.
Cellular and Molecular Gastroenterology and Hepatology
Journal of Crohn's and Colitis
Background Vedolizumab and anti-TNFα drugs are biologics that are used to treat moderate to sever... more Background Vedolizumab and anti-TNFα drugs are biologics that are used to treat moderate to severe ulcerative colitis (UC). In the UK, the decision of which drug to use at first-line is often based on a combination of clinical factors and the price of the drug (based on the one-year cost analysis from the NICE appraisal). The cost of the treatment pathway is rarely considered. Therefore, we investigated whether the choice of first-line biologic affects time-on-treatment and the overall treatment pathway costs by creating a cost model for vedolizumab followed by an anti-TNFα (VDZ–anti-TNFα) compared to anti-TNFα followed by vedolizumab (anti-TNFα–VDZ). Methods A targeted literature search identified 19 studies reporting time-on-treatment data for vedolizumab or anti-TNFαs in UC. We pooled data into four categories: 1) vedolizumab in people who were biologic-naïve (VDZ-1L), 2) anti-TNFα in people who were biologic-naïve (anti-TNFα-1L), 3) vedolizumab after first-line anti-TNFα (VDZ-2L...
Journal of Crohn's and Colitis
Background and Aims Inflammatory bowel disease colitis-associated dysplasia is managed with eithe... more Background and Aims Inflammatory bowel disease colitis-associated dysplasia is managed with either enhanced surveillance and endoscopic resection or prophylactic surgery. The rate of progression to cancer after a dysplasia diagnosis remains uncertain in many cases and patients have high thresholds for accepting proctocolectomy. Individualised discussion of management options is encouraged to take place between patients and their multidisciplinary teams for best outcomes. We aimed to develop a toolkit to support a structured, multidisciplinary and shared decision-making approach to discussions about dysplasia management options between clinicians and their patients. Methods Evidence from systematic literature reviews, mixed-methods studies conducted with key stakeholders, and decision-making expert recommendations were consolidated to draft consensus statements by the DECIDE steering group. These were then subjected to an international, multidisciplinary modified electronic Delphi pr...
On review of the patients whose cause of death were attributed to cancer, 12 did not have maligna... more On review of the patients whose cause of death were attributed to cancer, 12 did not have malignancy as initial HPN indication. Regarding mortality not linked to HPN, respiratory complications including pneumonia were the commonest causative factor (8/29, 28%). Conclusions This study showed that mortality was associated with the underlying disease condition resulting in the need for HPN or other co-morbidities rather than direct complications of HPN itself. REFERENCE 1. Pironi L, Joly F, Forbes A, et al. Long-term follow-up of patients on home parenteral nutrition in Europe: implications for intestinal transplantation. Gut 2011;60:1-5.
Gut, Jun 1, 2013
Further information on outcomes was gathered from individual consultation with patients. Results ... more Further information on outcomes was gathered from individual consultation with patients. Results 80 pregnancies in 57 patients with CD were identified.10 patients currently pregnant,9 patients(13 pregnancies) with incomplete data were excluded.Therefore,pregnancy outcomes of 57 pregnancies/38 patients (mean age: 30.7 years) were analysed. 31/38(82%) of patients had luminal disease,7/38(18%) perianal disease.36/38(95%) conceived naturally,1/38(2.5%) by assisted reproduction,1/38(2.5%) by IVF.25/57(44%) pregnancies were on no treatment in early pregnancy, 4/57(7%) on biologics [Infliximab 3/4(75%),Adalimumab1/4(25%)],6/57(10%) on biologics+t hiopurines(TPN),6/57(10%) on TPN,6/57(10%) on TPN+5-ASA,7/57(12%) on 5-ASA,2/57(3.5%) on steroids and 1/57(1.7%) on elemental diet.15/57(26%) pregnancies had flares,of which 5/15(33%) continued throughout pregnancy.5/15(33%) occurred in the 1st trimester,4/15(27%) in the 2nd, 1/15(7%) in the 3rd. Of all pregnancies with flares,9/15(60%) were on no CD therapy. The mean week of delivery was 39.5 weeks (36-42).32/46(70%) of deliveries were vaginal and 14/46(30%) by Caesarian section (CS). Of CS,8/14(57%) were planned due to perianal disease 5/8(63%) or obstetric indication 3/8(37%).Pregnancy outcomes were:live births 46/57(81%), miscarriages 10/57(17%), termination 1/57(2%). The mean birth weight (BW) of the newborns was 3 kg (1.9 kg-5.1 kg). 4/46(11%) of the babies were of low BW (<2.5kg). Neonatal issues were recorded in 5/46(11%); 1 diabetes mellitus,2 cardiac anomalies,1 with viral infection at 8 days, 1 cot death. Of the miscarriages, 5/10(50%) were on no CD therapy and 4/10(40%) flared in early pregnancy. The termination was due to use of medication unrelated to CD that could potentially cause congenital anomalies. The number of pregnancies in a specialist IBD clinic is high up to 20/year in this series highlighting a potential additional service need.A specialist obstetric medicine service can provide reassurance regarding safety of drugs in pregnancy,which in turn may reduce flare rates and result in good pregnancy outcomes. Observed outcomes did not fall outside that expected from larger reported series.
Frontline Gastroenterology, Jun 2, 2022
Eosinophilic oesophagitis is now being diagnosed more often, although there continues to be a sig... more Eosinophilic oesophagitis is now being diagnosed more often, although there continues to be a significant delay in the recognition of the condition in primary care, and among patients presenting with food bolus obstruction to other specialities like Ears, Nose and Throat and Accident & Emergency. The diagnosis requires endoscopy and biopsy, with six biopsies taken from at least two different areas of the oesophagus. The diagnostic threshold is > 15 eosinophils/high power field or 0.3 mm 2 . Dietary management although effective is often difficult to carry out due to poor adherence by patients and the need for a specialist dietitian and repeated biopsies. Orodispersible budesonide is very effective for inducing remission and maintaining it long term, with fewer biopsies. Newer targeted biological agents are promising in the treatment of patients who have not responded to conventional treatments. Dilatation of strictures in this condition is safe.
Journal of the Royal College of Physicians of Edinburgh, Dec 1, 2020
Gastrointestinal Endoscopy, Apr 1, 2012
Frontline Gastroenterology, May 25, 2023
Background and aims Healthcare quality improvement (QI) is the systematic process to continuously... more Background and aims Healthcare quality improvement (QI) is the systematic process to continuously improve the quality of care and outcomes for patients. The landmark Inflammatory Bowel Disease (IBD) UK National Audits provided a means to measure the variation in care, highlighting the need to define the standards of excellence in IBD care. Through a consensus approach, we aimed to establish key performance indicators (KPIs), providing reliable benchmarks for IBD care delivery in UK. Methods KPIs that measure critical aspects of a patient journey within an IBD service were identified though stakeholder meetings. A twostage Delphi consensus was then conducted. The first involved a multidisciplinary team of IBD clinicians and patients to refine definitions and methodology. The second stage assessed feasibility and utility of the proposed QI process by surveying gastroenterology services across UK. Results First, the four proposed KPIs were refined and included time from primary care referral to diagnosis in secondary care, time to treatment recommendation following a diagnosis, appropriate use of steroids and advanced therapies prescreening and assessment. Second, the Delphi consensus reported >85% agreement on the feasibility of local adoption of the QI process and >75% agreement on the utility of benchmarking of the KPIs. Conclusions Through a structured approach, we propose quantifiable KPIs for benchmarking to improve and reduce the individual variation in IBD care across the UK. ⇒ This British Society of Gastroenterology IBD QI initiative will focus on the performance of IBD services against defined KPIs and will complement the IBD UK benchmarking tool which assess performance against defined IBD standards via patient surveys and service self-assessments.
transcribed and analysed for IBD outcomes elicited by clinicians (or volunteered by patients), in... more transcribed and analysed for IBD outcomes elicited by clinicians (or volunteered by patients), including specific items required for Harvey-Bradshaw Index (HBI) and Simple Clinical Colitis Activity Index (SCCAI). Results Most commonly elicited outcomes are shown in the table 1. HBI or SCCAI were collected in only 4 (8%) of consultations. In the remainder, domains of HBI and SCCAI were discussed in variable detail. Complete HBI coverage: 5/29 (17%); symptom components of HBI (wellbeing, liquid stools, abdominal pain): 16/29 (55%). No Crohn's disease consultation involved specific discussions about symptoms over past 24 hrs (including 2 where HBI was calculated). Complete SCCAI coverage: only 1 consultation. Partial coverage (5 out of 6 SCCAI domains): 8/21 (38%). Symptoms were never specifically defined over past 3 days. Certain symptoms were elicited significantly more often by nurses than doctors (p<0.05), and coverage varied by disease severity. Interviews are under way to explore views, barriers and facilitators to standardisation of outcomes assessment. Conclusions There is high variability in breadth, depth and quantification of outcomes during routine clinical assessments. Most domains for activity indices were elicited but formal scoring and assessment for a fixed time period was rare. Standardised outcomes may be better-captured directly from patients (PROMs) than via clinician-generated indices.
Journal of Crohn's and Colitis, 2022
Background Vedolizumab, a gut-selective monoclonal antibody targeting α4β7-integrin, was recently... more Background Vedolizumab, a gut-selective monoclonal antibody targeting α4β7-integrin, was recently licenced as a subcutaneous (SC) preparation after demonstrating efficacy compared to placebo at maintaining remission in IBD patients who had a clinical response to intravenous (IV) induction therapy. We aimed to assess real-world experience of switching patients to SC administration. Methods Patients across 10 UK centres who had completed induction with IV vedolizumab were offered SC therapy. Demographic data and baseline disease characteristics (disease type and behaviour, medication history) were collected, alongside biochemical markers (C-reactive protein, faecal calprotectin), disease activity scores (SCCAI, partial Mayo or modified Harvey Bradshaw Index) and quality of life scores (IBD-Control-8) at baseline (defined as the first dose of SC medication), 8 and 24. Data was also collected on drug persistence, hospital admissions, steroid use and reported adverse events. Results 351 ...
Gastroenterology, 2020
BACKGROUND AIMS Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topi... more BACKGROUND AIMS Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear if these drugs are effective for long-term maintenance of remission. METHODS We performed a double-blind trial to compare the efficacy and safety of 2 doses of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histological relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n=68), BOT 1.0 mg twice daily (n=68), or placebo twice daily (n=68) for up to 48 weeks. RESULTS At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission, compared with 4.4% of patients in the placebo group (P<.001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment. CONCLUSIONS In a phase 3 trial, up to 48 weeks of treatment with BOT (.5 mg or 1.0 mg, twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. (Funded by Dr. Falk Pharma GmbH; EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.).
Gut, Jun 1, 2016
endoscopists reported hiatus hernia length in only 38% of cases, with doctor (any grade) reportin... more endoscopists reported hiatus hernia length in only 38% of cases, with doctor (any grade) reporting at 62%. Interestingly overall only 32% of reports made any mention of proton pump inhibitor (PPI) use or advised of PPI initiation. Of the total (n = 250) 7 cases of dysplasia and 4 cases of adenocarcinoma were detected. The single detected high-grade dysplasia was referred appropriately for UGI multidisciplinary team input. Two cases of indefinite dysplasia were noted, and repeat endoscopy planned within a 6 month period. The overall finding of 11 cases (4.4%) of dysplasia or malignancy was in keeping with expected detection rates as reported by recent meta-analyses.(Qiao 2015) Conclusion While dysplasia and adenocarcinoma detection rates are within acceptable ranges, improved adherence to the 'minimum dataset' is needed. We have recommended serial clinical update sessions for endoscopists and planned further re-audit.
Frontline Gastroenterology, Sep 21, 2018
Background Endoscopic antireflux radiofrequency treatment (Stretta) offers a therapeutic alternat... more Background Endoscopic antireflux radiofrequency treatment (Stretta) offers a therapeutic alternative for patients suffering from refractory gastrooesophageal reflux disease (GORD). Current evidence suggests that the treatment may improve symptoms of GORD and decrease requirement for proton pump inhibitor (PPI) therapy. Methods Prospective assessment of patients undergoing Stretta, between October 2014 and February 2016, in a UK tertiary referral centre was carried. All patients were assessed for suitability using endoscopy, contrast studies, and pH and manometry studies. The Gastrooesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) was used to evaluate symptoms along with PPI dependency, pre-Stretta and post-Stretta treatment. Patients were followed up by outpatient clinic appointment and telephone consultation. Results Fifty consecutive patients were followed up for a median of 771 days (range 499-1162) following treatment with Stretta. The average GERD-HRQL score improved from 46.2/75 (±14.2) preprocedure to 15.2/75 (±17.3) postprocedure. Dissatisfaction with GORD as measured in the GERD-HRQL decreased from 100% to 10% with three patients showing no improvement (non-responders) at follow up and two late failures at the time of this review. There were no complications and all cases were carried out as day cases.
Frontline Gastroenterology, Jul 19, 2016
Background Gastrointestinal stromal tumours (GISTs) are rare mesenchymal tumours of the gastroint... more Background Gastrointestinal stromal tumours (GISTs) are rare mesenchymal tumours of the gastrointestinal tract. We retrospectively reviewed the clinical management of all patients with GIST presenting to a regional multidisciplinary upper gastrointestinal cancer group in the north of England. Methods Clinical, pathological, immunohistochemical treatment strategies, follow-up and outcome data on all patients with GIST between 2007 and 2012 were reviewed. Tumours were categorised by risk according to the National Institutes of Health (NIH) and AFIP models. Results 36 (85.7%) of 42 tumours were located in the stomach, 5 (11.9%) in the small intestine and 1 (2.4%) in the oesophagus. Median age of patients was 68 (range 43-91) years. 24 patients (57.1%) were female. Tumour size ranged from 1.0 to 12.7 cm with mean size of 5.46 cm. Metastasis was present in 19 (45.2%) patients at diagnosis with distant metastases in 12 patients. Liver was the most common site of metastases. Histology and immunohistochemical analysis was available in 32 (76.2%) patients. Most common histology was spindle cell morphology 17/32 (53.1%) followed by epithelioid 9/32 (28.1%) and mixed morphology 5/32 (15.6%). The positive rate for KIT protein (CD117) was 90.6%, while that for CD34 was 75.0%. 12/25 (48.0%) and 8/23 (34.8%) patients were categorised as high risk as per NIH and AFIP risk scores, respectively. 23/42 (54.8%) patients underwent surgical resection, after which 5/23 (21.7%) had adjuvant imatinib therapy. Imatinib was given as primary therapy in 14/42 (33.3%) patients. Conclusions Surgery alone may not be a curative treatment for GISTs. Targeted therapy with imatinib may play an important role in the treatment of GISTs. Further risk categorisation models may be needed to evaluate GIST behaviour and prognosis.
Cellular and Molecular Gastroenterology and Hepatology
Journal of Crohn's and Colitis
Background Vedolizumab and anti-TNFα drugs are biologics that are used to treat moderate to sever... more Background Vedolizumab and anti-TNFα drugs are biologics that are used to treat moderate to severe ulcerative colitis (UC). In the UK, the decision of which drug to use at first-line is often based on a combination of clinical factors and the price of the drug (based on the one-year cost analysis from the NICE appraisal). The cost of the treatment pathway is rarely considered. Therefore, we investigated whether the choice of first-line biologic affects time-on-treatment and the overall treatment pathway costs by creating a cost model for vedolizumab followed by an anti-TNFα (VDZ–anti-TNFα) compared to anti-TNFα followed by vedolizumab (anti-TNFα–VDZ). Methods A targeted literature search identified 19 studies reporting time-on-treatment data for vedolizumab or anti-TNFαs in UC. We pooled data into four categories: 1) vedolizumab in people who were biologic-naïve (VDZ-1L), 2) anti-TNFα in people who were biologic-naïve (anti-TNFα-1L), 3) vedolizumab after first-line anti-TNFα (VDZ-2L...
Journal of Crohn's and Colitis
Background and Aims Inflammatory bowel disease colitis-associated dysplasia is managed with eithe... more Background and Aims Inflammatory bowel disease colitis-associated dysplasia is managed with either enhanced surveillance and endoscopic resection or prophylactic surgery. The rate of progression to cancer after a dysplasia diagnosis remains uncertain in many cases and patients have high thresholds for accepting proctocolectomy. Individualised discussion of management options is encouraged to take place between patients and their multidisciplinary teams for best outcomes. We aimed to develop a toolkit to support a structured, multidisciplinary and shared decision-making approach to discussions about dysplasia management options between clinicians and their patients. Methods Evidence from systematic literature reviews, mixed-methods studies conducted with key stakeholders, and decision-making expert recommendations were consolidated to draft consensus statements by the DECIDE steering group. These were then subjected to an international, multidisciplinary modified electronic Delphi pr...