Eric Manusama - Academia.edu (original) (raw)
Papers by Eric Manusama
British Journal of Surgery
HPB, 2016
Conclusion: Preliminary results of this study describe histopathological changes following weight... more Conclusion: Preliminary results of this study describe histopathological changes following weight reduction surgery and suggest that hepatic steatosis, fibrosis and NAFLD activity score are reduced 3 months after surgery. (Registration number: NCT01619215). Disclosure: The clinical trial is financially supported by NPST.
textabstractIsolated limb perfusion (lLP) with high dose TNFa in combination with IFNr and melpha... more textabstractIsolated limb perfusion (lLP) with high dose TNFa in combination with IFNr and melphalan in patients with melanoma in transit metastases confined to the limb has recently been reported to result in much higher complete tumor response rates than after the standard therapy of ILP with melphalan alone: 90 % vs 54 % complete remissionl .'. Moreover the same protocol of ILP when applied as an induction bio-chemotherapy in patients with irresectabIe extremity soft tissue sarcomas. was reported to result in about 85 % response rates rendering most tumors resectable and resulting in a > 80% limb salvage rate'·'. The tumor response in many patients in both patient groups was characterized by an immediate (within 3 days) and grossly visible reaction to treatment, which shows a remarkable similarity to that observed in animal tumor models after systemic administration of TNFa. ILP became the first setting, in which effective concentrations of TN Fa could be reached a...
New England Journal of Medicine
Cancers
The guidelines for metastatic colorectal cancer crudely state that the best local treatment shoul... more The guidelines for metastatic colorectal cancer crudely state that the best local treatment should be selected from a ‘toolbox’ of techniques according to patient- and treatment-related factors. We created an interdisciplinary, consensus-based algorithm with specific resectability and ablatability criteria for the treatment of colorectal liver metastases (CRLM). To pursue consensus, members of the multidisciplinary COLLISION and COLDFIRE trial expert panel employed the RAND appropriateness method (RAM). Statements regarding patient, disease, tumor and treatment characteristics were categorized as appropriate, equipoise or inappropriate. Patients with ECOG≤2, ASA≤3 and Charlson comorbidity index ≤8 should be considered fit for curative-intent local therapy. When easily resectable and/or ablatable (stage IVa), (neo)adjuvant systemic therapy is not indicated. When requiring major hepatectomy (stage IVb), neo-adjuvant systemic therapy is appropriate for early metachronous disease and to...
Trials, Apr 25, 2019
BackgroundInfected necrosis complicates 10% of all acute pancreatitis episodes and is associated ... more BackgroundInfected necrosis complicates 10% of all acute pancreatitis episodes and is associated with 15–20% mortality. The current standard treatment for infected necrotizing pancreatitis is the step-up approach (catheter drainage, followed, if necessary, by minimally invasive necrosectomy). Catheter drainage is preferably postponed until the stage of walled-off necrosis, which usually takes 4 weeks. This delay stems from the time when open necrosectomy was the standard. It is unclear whether such delay is needed for catheter drainage or whether earlier intervention could actually be beneficial in the current step-up approach. The POINTER trial investigates if immediate catheter drainage in patients with infected necrotizing pancreatitis is superior to the current practice of postponed intervention.MethodsPOINTER is a randomized controlled multicenter superiority trial. All patients with necrotizing pancreatitis are screened for eligibility. In total, 104 adult patients with (suspected) infected necrotizing pancreatitis will be randomized to immediate (within 24 h) catheter drainage or current standard care involving postponed catheter drainage. Necrosectomy, if necessary, is preferably postponed until the stage of walled-off necrosis, in both treatment arms. The primary outcome is the Comprehensive Complication Index (CCI), which covers all complications between randomization and 6-month follow up. Secondary outcomes include mortality, complications, number of (repeat) interventions, hospital and intensive care unit (ICU) lengths of stay, quality-adjusted life years (QALYs) and direct and indirect costs. Standard follow-up is at 3 and 6 months after randomization.DiscussionThe POINTER trial investigates if immediate catheter drainage in infected necrotizing pancreatitis reduces the composite endpoint of complications, as compared with the current standard treatment strategy involving delay of intervention until the stage of walled-off necrosis.Trial registrationISRCTN, 33682933. Registered on 6 August 2015. Retrospectively registered.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3315-6) contains supplementary material, which is available to authorized users.
Colorectal Disease
Aim This study aimed to determine predictive factors for the circumferential resection margin (CR... more Aim This study aimed to determine predictive factors for the circumferential resection margin (CRM) within two northern European countries with supposed similarity in providing rectal cancer care. Method Data for all patients undergoing rectal resection for clinical tumour node metastasis (TNM) stage I-III rectal cancer were extracted from the Swedish ColoRectal Cancer Registry and the Dutch ColoRectal Audit (2011-2015). Separate analyses were performed for cT1-3 and cT4 stage. Predictive factors for the CRM were determined using univariable and multivariable logistic regression analyses. Results A total of 6444 Swedish and 12 089 Dutch patients were analysed. Over time the number of hospitals treating rectal cancer decreased from 52 to 42 in Sweden, and 82 to 79 in the Netherlands. In the Swedish population, proportions of cT4 stage (17% vs 8%), multivisceral resection (14% vs 7%) and abdominoperineal excision (APR) (37% vs 31%) were higher. The overall proportion of patients with a positive CRM (CRM+) was 7.8% in Sweden and 5.4% in the Netherlands. In both populations with cT1-3 stage disease, common independent risk factors for CRM+ were cT3, APR and multivisceral resection. No common risk factors for CRM+ in cT4 stage disease were found. An independent impact of hospital volume on CRM+ could be demonstrated for the cT1-3 Dutch population. Conclusion Within two northern European countries with implemented clinical auditing, rectal cancer care might potentially be improved by further optimizing the treatment of distal and locally advanced rectal cancer.
Lancet (London, England), Jan 3, 2017
Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive ... more Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composit...
Regional Cancer Treatment, 1994
Trials, 2011
In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A ... more In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission.
Hernia
Isolated limb perfusion (lLP) with high dose TNFa in combination with IFNr and melphalan in patie... more Isolated limb perfusion (lLP) with high dose TNFa in combination with IFNr and melphalan in patients with melanoma in transit metastases confined to the limb has recently been reported to result in much higher complete tumor response rates than after the standard therapy of ILP with melphalan alone: 90 % vs 54 % complete remissionl .'. Moreover the same protocol of ILP when applied as an induction bio-chemotherapy in patients with irresectabIe extremity soft tissue sarcomas. was reported to result in about 85 % response rates rendering most tumors resectable and resulting in a > 80% limb salvage rate'·'. The tumor response in many patients in both patient groups was characterized by an immediate (within 3 days) and grossly visible reaction to treatment, which shows a remarkable similarity to that observed in animal tumor models after systemic administration of TNFa. ILP became the first setting, in which effective concentrations of TN Fa could be reached and a reprodu...
European Journal of Surgical Oncology (EJSO), 1996
Isolated limb perfusion (ILP) with TNFa, IFNy and melphalan causes impressive tumour reduction in... more Isolated limb perfusion (ILP) with TNFa, IFNy and melphalan causes impressive tumour reduction in patients with irresectable soft tissue sarcomas with a high limb salvage rate. Since this therapy could be of value in patients with progressive osteosarcoma, we performed a study in an osteosarcoma tumour model in the rat. The ROS-! osteosareoma was implanted s.c. in the hind leg of WAG rats. Rats were divided in four groups: rats that underwent ILP with perfusate alone, TNFa alone, melphalan alone or their combination. Almost all rats, treated with a sham ILP or a perfusion with 40 #g melphalan, showed progressive disease (PD) (616 and 516). After perfusion with 50 #g TNFct alone a varied response was observed: 216 PD, 216 no change (NC) and 216 a complete remission (CR). After combined perfusion: 3/6 rats had a partial remission and 316 a CR. The best and most consistent responses are obtained by combining TNF= and melphalan. The discrepancy with the in vitro sensitivity of ROS-I indicates that indirect effects are important in this tumour model.
Annals of Surgery, 2000
To evaluate the potential of isolated limb perfusion (ILP) for efficient and tumor-specific adeno... more To evaluate the potential of isolated limb perfusion (ILP) for efficient and tumor-specific adenovirus-mediated gene transfer in sarcoma-bearing rats.
Seminars in Surgical Oncology
ABSTRACT
The New England journal of medicine, Jan 20, 2014
Early enteral feeding through a nasoenteric feeding tube is often used in patients with severe ac... more Early enteral feeding through a nasoenteric feeding tube is often used in patients with severe acute pancreatitis to prevent gut-derived infections, but evidence to support this strategy is limited. We conducted a multicenter, randomized trial comparing early nasoenteric tube feeding with an oral diet at 72 hours after presentation to the emergency department in patients with acute pancreatitis. We enrolled patients with acute pancreatitis who were at high risk for complications on the basis of an Acute Physiology and Chronic Health Evaluation II score of 8 or higher (on a scale of 0 to 71, with higher scores indicating more severe disease), an Imrie or modified Glasgow score of 3 or higher (on a scale of 0 to 8, with higher scores indicating more severe disease), or a serum C-reactive protein level of more than 150 mg per liter. Patients were randomly assigned to nasoenteric tube feeding within 24 hours after randomization (early group) or to an oral diet initiated 72 hours after p...
Lancet (London, England), Jan 26, 2015
In patients with mild gallstone pancreatitis, cholecystectomy during the same hospital admission ... more In patients with mild gallstone pancreatitis, cholecystectomy during the same hospital admission might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy of interval cholecystectomy. However, evidence to support same-admission cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare same-admission and interval cholecystectomy, with the hypothesis that same-admission cholecystectomy would reduce the risk of recurrent gallstone-related complications without increasing the difficulty of surgery. For this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, inpatients recovering from mild gallstone pancreatitis at 23 hospitals in the Netherlands (with hospital discharge foreseen within 48 h) were assessed for eligibility. Adult patients (aged ≥18 years) were eligible for randomisation if they...
British Journal of Surgery
HPB, 2016
Conclusion: Preliminary results of this study describe histopathological changes following weight... more Conclusion: Preliminary results of this study describe histopathological changes following weight reduction surgery and suggest that hepatic steatosis, fibrosis and NAFLD activity score are reduced 3 months after surgery. (Registration number: NCT01619215). Disclosure: The clinical trial is financially supported by NPST.
textabstractIsolated limb perfusion (lLP) with high dose TNFa in combination with IFNr and melpha... more textabstractIsolated limb perfusion (lLP) with high dose TNFa in combination with IFNr and melphalan in patients with melanoma in transit metastases confined to the limb has recently been reported to result in much higher complete tumor response rates than after the standard therapy of ILP with melphalan alone: 90 % vs 54 % complete remissionl .'. Moreover the same protocol of ILP when applied as an induction bio-chemotherapy in patients with irresectabIe extremity soft tissue sarcomas. was reported to result in about 85 % response rates rendering most tumors resectable and resulting in a > 80% limb salvage rate'·'. The tumor response in many patients in both patient groups was characterized by an immediate (within 3 days) and grossly visible reaction to treatment, which shows a remarkable similarity to that observed in animal tumor models after systemic administration of TNFa. ILP became the first setting, in which effective concentrations of TN Fa could be reached a...
New England Journal of Medicine
Cancers
The guidelines for metastatic colorectal cancer crudely state that the best local treatment shoul... more The guidelines for metastatic colorectal cancer crudely state that the best local treatment should be selected from a ‘toolbox’ of techniques according to patient- and treatment-related factors. We created an interdisciplinary, consensus-based algorithm with specific resectability and ablatability criteria for the treatment of colorectal liver metastases (CRLM). To pursue consensus, members of the multidisciplinary COLLISION and COLDFIRE trial expert panel employed the RAND appropriateness method (RAM). Statements regarding patient, disease, tumor and treatment characteristics were categorized as appropriate, equipoise or inappropriate. Patients with ECOG≤2, ASA≤3 and Charlson comorbidity index ≤8 should be considered fit for curative-intent local therapy. When easily resectable and/or ablatable (stage IVa), (neo)adjuvant systemic therapy is not indicated. When requiring major hepatectomy (stage IVb), neo-adjuvant systemic therapy is appropriate for early metachronous disease and to...
Trials, Apr 25, 2019
BackgroundInfected necrosis complicates 10% of all acute pancreatitis episodes and is associated ... more BackgroundInfected necrosis complicates 10% of all acute pancreatitis episodes and is associated with 15–20% mortality. The current standard treatment for infected necrotizing pancreatitis is the step-up approach (catheter drainage, followed, if necessary, by minimally invasive necrosectomy). Catheter drainage is preferably postponed until the stage of walled-off necrosis, which usually takes 4 weeks. This delay stems from the time when open necrosectomy was the standard. It is unclear whether such delay is needed for catheter drainage or whether earlier intervention could actually be beneficial in the current step-up approach. The POINTER trial investigates if immediate catheter drainage in patients with infected necrotizing pancreatitis is superior to the current practice of postponed intervention.MethodsPOINTER is a randomized controlled multicenter superiority trial. All patients with necrotizing pancreatitis are screened for eligibility. In total, 104 adult patients with (suspected) infected necrotizing pancreatitis will be randomized to immediate (within 24 h) catheter drainage or current standard care involving postponed catheter drainage. Necrosectomy, if necessary, is preferably postponed until the stage of walled-off necrosis, in both treatment arms. The primary outcome is the Comprehensive Complication Index (CCI), which covers all complications between randomization and 6-month follow up. Secondary outcomes include mortality, complications, number of (repeat) interventions, hospital and intensive care unit (ICU) lengths of stay, quality-adjusted life years (QALYs) and direct and indirect costs. Standard follow-up is at 3 and 6 months after randomization.DiscussionThe POINTER trial investigates if immediate catheter drainage in infected necrotizing pancreatitis reduces the composite endpoint of complications, as compared with the current standard treatment strategy involving delay of intervention until the stage of walled-off necrosis.Trial registrationISRCTN, 33682933. Registered on 6 August 2015. Retrospectively registered.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3315-6) contains supplementary material, which is available to authorized users.
Colorectal Disease
Aim This study aimed to determine predictive factors for the circumferential resection margin (CR... more Aim This study aimed to determine predictive factors for the circumferential resection margin (CRM) within two northern European countries with supposed similarity in providing rectal cancer care. Method Data for all patients undergoing rectal resection for clinical tumour node metastasis (TNM) stage I-III rectal cancer were extracted from the Swedish ColoRectal Cancer Registry and the Dutch ColoRectal Audit (2011-2015). Separate analyses were performed for cT1-3 and cT4 stage. Predictive factors for the CRM were determined using univariable and multivariable logistic regression analyses. Results A total of 6444 Swedish and 12 089 Dutch patients were analysed. Over time the number of hospitals treating rectal cancer decreased from 52 to 42 in Sweden, and 82 to 79 in the Netherlands. In the Swedish population, proportions of cT4 stage (17% vs 8%), multivisceral resection (14% vs 7%) and abdominoperineal excision (APR) (37% vs 31%) were higher. The overall proportion of patients with a positive CRM (CRM+) was 7.8% in Sweden and 5.4% in the Netherlands. In both populations with cT1-3 stage disease, common independent risk factors for CRM+ were cT3, APR and multivisceral resection. No common risk factors for CRM+ in cT4 stage disease were found. An independent impact of hospital volume on CRM+ could be demonstrated for the cT1-3 Dutch population. Conclusion Within two northern European countries with implemented clinical auditing, rectal cancer care might potentially be improved by further optimizing the treatment of distal and locally advanced rectal cancer.
Lancet (London, England), Jan 3, 2017
Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive ... more Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composit...
Regional Cancer Treatment, 1994
Trials, 2011
In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A ... more In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission.
Hernia
Isolated limb perfusion (lLP) with high dose TNFa in combination with IFNr and melphalan in patie... more Isolated limb perfusion (lLP) with high dose TNFa in combination with IFNr and melphalan in patients with melanoma in transit metastases confined to the limb has recently been reported to result in much higher complete tumor response rates than after the standard therapy of ILP with melphalan alone: 90 % vs 54 % complete remissionl .'. Moreover the same protocol of ILP when applied as an induction bio-chemotherapy in patients with irresectabIe extremity soft tissue sarcomas. was reported to result in about 85 % response rates rendering most tumors resectable and resulting in a > 80% limb salvage rate'·'. The tumor response in many patients in both patient groups was characterized by an immediate (within 3 days) and grossly visible reaction to treatment, which shows a remarkable similarity to that observed in animal tumor models after systemic administration of TNFa. ILP became the first setting, in which effective concentrations of TN Fa could be reached and a reprodu...
European Journal of Surgical Oncology (EJSO), 1996
Isolated limb perfusion (ILP) with TNFa, IFNy and melphalan causes impressive tumour reduction in... more Isolated limb perfusion (ILP) with TNFa, IFNy and melphalan causes impressive tumour reduction in patients with irresectable soft tissue sarcomas with a high limb salvage rate. Since this therapy could be of value in patients with progressive osteosarcoma, we performed a study in an osteosarcoma tumour model in the rat. The ROS-! osteosareoma was implanted s.c. in the hind leg of WAG rats. Rats were divided in four groups: rats that underwent ILP with perfusate alone, TNFa alone, melphalan alone or their combination. Almost all rats, treated with a sham ILP or a perfusion with 40 #g melphalan, showed progressive disease (PD) (616 and 516). After perfusion with 50 #g TNFct alone a varied response was observed: 216 PD, 216 no change (NC) and 216 a complete remission (CR). After combined perfusion: 3/6 rats had a partial remission and 316 a CR. The best and most consistent responses are obtained by combining TNF= and melphalan. The discrepancy with the in vitro sensitivity of ROS-I indicates that indirect effects are important in this tumour model.
Annals of Surgery, 2000
To evaluate the potential of isolated limb perfusion (ILP) for efficient and tumor-specific adeno... more To evaluate the potential of isolated limb perfusion (ILP) for efficient and tumor-specific adenovirus-mediated gene transfer in sarcoma-bearing rats.
Seminars in Surgical Oncology
ABSTRACT
The New England journal of medicine, Jan 20, 2014
Early enteral feeding through a nasoenteric feeding tube is often used in patients with severe ac... more Early enteral feeding through a nasoenteric feeding tube is often used in patients with severe acute pancreatitis to prevent gut-derived infections, but evidence to support this strategy is limited. We conducted a multicenter, randomized trial comparing early nasoenteric tube feeding with an oral diet at 72 hours after presentation to the emergency department in patients with acute pancreatitis. We enrolled patients with acute pancreatitis who were at high risk for complications on the basis of an Acute Physiology and Chronic Health Evaluation II score of 8 or higher (on a scale of 0 to 71, with higher scores indicating more severe disease), an Imrie or modified Glasgow score of 3 or higher (on a scale of 0 to 8, with higher scores indicating more severe disease), or a serum C-reactive protein level of more than 150 mg per liter. Patients were randomly assigned to nasoenteric tube feeding within 24 hours after randomization (early group) or to an oral diet initiated 72 hours after p...
Lancet (London, England), Jan 26, 2015
In patients with mild gallstone pancreatitis, cholecystectomy during the same hospital admission ... more In patients with mild gallstone pancreatitis, cholecystectomy during the same hospital admission might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy of interval cholecystectomy. However, evidence to support same-admission cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare same-admission and interval cholecystectomy, with the hypothesis that same-admission cholecystectomy would reduce the risk of recurrent gallstone-related complications without increasing the difficulty of surgery. For this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, inpatients recovering from mild gallstone pancreatitis at 23 hospitals in the Netherlands (with hospital discharge foreseen within 48 h) were assessed for eligibility. Adult patients (aged ≥18 years) were eligible for randomisation if they...