Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868] (original) (raw)
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Lancet (London, England), 2017
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...
Gut, 2017
Minimally invasive surgical necrosectomy and endoscopic necrosectomy, compared with open necrosectomy, might improve outcomes in necrotising pancreatitis, especially in critically ill patients. Evidence from large comparative studies is lacking. We combined original and newly collected data from 15 published and unpublished patient cohorts (51 hospitals; 8 countries) on pancreatic necrosectomy for necrotising pancreatitis. Death rates were compared in patients undergoing open necrosectomy versus minimally invasive surgical or endoscopic necrosectomy. To adjust for confounding and to study effect modification by clinical severity, we performed two types of analyses: logistic multivariable regression and propensity score matching with stratification according to predicted risk of death at baseline (low: <5%; intermediate: ≥5% to <15%; high: ≥15% to <35%; and very high: ≥35%). Among 1980 patients with necrotising pancreatitis, 1167 underwent open necrosectomy and 813 underwent...
Retrospective Validation of an Algorithmic Treatment Pathway for Necrotizing Pancreatitis
The American Surgeon, 2019
The role of surgical intervention for necrotizing pancreatitis has evolved; however, no widely accepted algorithm has been established to guide timing and optimal modality in the minimally invasive era. This study aimed to retrospectively validate an established institutional timing- and physiologic-based algorithm constructed from evidence-based guidelines in a high-volume hepatopancreatobiliary center. Patients with necrotizing pancreatitis requiring early (≤six weeks from symptom onset) or delayed (>six weeks) surgical intervention were reviewed over a four-year period (n = 100). Early intervention was provided through laparoscopic drain-guided retroperitoneal debridement (n = 15) after failed percutaneous drainage unless they required an emergent laparotomy (due to abdominal compartment syndrome, bowel necrosis/perforation, or hemorrhage) after which conservative, sequential open necrosectomy was performed (n = 47). Robot-assisted (n = 16) versus laparoscopic (n = 22) transga...
Management of necrotizing pancreatitis and its outcome in a secondary healthcare institution
International Surgery Journal
Background: Surgical debridement is the “gold standard” for infected pancreatic necrosis. Advances in imaging methods and minimal access techniques have changed the management of many surgical conditions and even infected pancreatic necrosis has successfully been treated in selected patients. However, technical advances don’t obviate sound clinical judgment. Aim was to consider recent advances in minimal access surgery, this article retrospectively analyses the role of open surgery and laparoscopic techniques in the management of necrotizing pancreatitis.Methods: A retrospective study of 30 cases of pancreatic necrosectomy admitted and managed during 2012-2016 was carried out and compared with results available in the existing literature.Results: Out of 30 cases, 20 were men and 10 were women. Patients' age ranged from 23 to 70 years (mean age - 49.8 years). The mean operating time was 103.8 min (range, 60-120 min). Timing of necrosectomy was 21-32 days (average - 25.5 days). Th...
Trials, 2019
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.
Survey of trends in minimally invasive intervention for necrotizing pancreatitis
ANZ Journal of Surgery, 2011
Minimally invasive techniques to manage infected pancreatic necrosis have been recently developed and changes in their pattern of use are unknown. The aims of this survey were to determine the trends in the role of minimally invasive techniques to manage infected complications of necrotizing pancreatitis and the barriers to performing minimally invasive necrosectomy in Australia and New Zealand. Methods: Members of the Australian and New Zealand Hepatic Pancreatic and Biliary Association were surveyed. Participant demographics and necrotizing pancreatitis caseload were determined. The perceived role of percutaneous catheter drainage and minimally invasive necrosectomy for pancreatic abscess, infected pseudocyst and infected pancreatic necrosis were scored on Likert scales, comparing 2002 with 2007. Barriers to performing minimally invasive necrosectomy were scored. Results: The response rate was 49% (44/90). Between 2002 and 2007, the role of percutaneous catheter drainage became more important as primary (P = 0.05) and secondary (P = 0.01) treatment for pancreatic abscess, and prior to minimally invasive necrosectomy for abscess, pseudocyst and necrosis (P < 0.01). Minimally invasive necrosectomy became increasingly important as primary treatment for infected necrosis (P < 0.01) and had been used by 47% of respondents. The greatest barriers to performing minimally invasive necrosectomy were lack of training and experience in the techniques, and the anatomical position and complexity of the target lesion. Conclusion: Minimally invasive techniques have an increasingly important perceived role in the management of pancreatic abscess, infected pseudocyst and infected pancreatic necrosis. Further evidence is required to determine the best techniques for treating each form of infection associated with necrotizing pancreatitis.
Surgical Laparoscopy, Endoscopy & Percutaneous Techniques, 2013
The purpose of this meta-analysis and systematic review is to compare minimally invasive necrosectomy (MIN) versus open necrosectomy (ON) surgery for infected necrosis of acute pancreatitis. Methods: One randomized controlled trial and 3 clinical controlled trials were selected, with a total of 336 patients (215 patients who underwent MIN and 121 patients underwent ON) included after searching in the following databases:
Progress in the management of necrotizing pancreatitis
Expert Review of Gastroenterology & Hepatology, 2010
Pancreatic necrosis, a complication of severe pancreatitis, may become infected, resulting in significant morbidity and potential mortality. Infected necrosis was heretofore considered a surgical condition, and despite aggressive operative management, the mortality remained high. With a better understanding of the natural history of necrosis, established methods to diagnose infection and the increasing use of minimally invasive techniques, less aggressive therapies have been utilized with some success. The present study evaluated a step-up approach for the treatment of infected pancreatic necrosis, utilizing endoscopic and percutaneous techniques, and if ineffective, necrosectomy with a minimally invasive retroperitoneal approach. They compared this step-up approach to the standard open necrosectomy. They demonstrated that when using such an approach compared with open necrosectomy, the frequency of major complications such as organ failure, perforation, fistula or even death was significantly less than in those who received conventional open necrosectomy. Indeed, for those randomized to the step-up approach, roughly a third of the patients were successfully treated with percutaneous drainage alone. In the long-term, development of diabetes was also less frequent in those receiving less aggressive therapy. These findings, in combination with other reports, suggest that the dogma that open necrosectomy is mandatory for all patients with infected necrosis should be re-evaluated, and that less aggressive treatments as part of a multidisciplinary approach can reduce morbidity and mortality.