Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial (original) (raw)
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BMC surgery, 2006
The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, includin...
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 We combined original and newly collected data from 15 published and unpublished patient cohorts (51 hospitals; 8 countries) on pancreatic necrosectomy for necrotising pancreatitis.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...
Endoscopic Management of Infected Necrotizing Pancreatitis: an Evidence-Based Approach
Current treatment options in gastroenterology, 2018
Endoscopic management of infected necrotizing pancreatitis has evolved rapidly over the past years and there have been interesting innovations in this field. This review provides an update on the most recently published literature regarding endoscopic management of infected necrotizing pancreatitis. A recent randomized trial demonstrated no difference in mortality and major morbidity between endoscopic and surgical step-up treatment of infected necrotizing pancreatitis. However, endoscopic therapy resulted in shorter hospital stay and less pancreatic fistulas. Various innovations have been investigated with the aim to further optimize endoscopic therapy, in particular lumen-apposing metal stents. While major stent-related complications were also reported, findings from recent studies indicated that their use was associated with higher resolution rates of walled-off necrosis compared to double-pigtail stents. Other innovations, such as the multiple gateway technique and dual-modality...
Pancreas, 2014
Infected walled-off pancreatic necrosis (WOPN) is a complication of acute pancreatitis requiring intervention. Surgery is associated with considerable morbidity. Percutaneous catheter drainage (PCD), initial therapy in the step-up approach, minimizes complications. Direct endoscopic necrosectomy (DEN) has demonstrated safety and efficacy. We compared outcome and health care utilization of DEN versus step-up approach. This was a matched cohort study using a prospective registry. Twelve consecutive DEN patients were matched with 12 step-up approach patients. Outcomes were clinical resolution after primary therapeutic modality, new organ failure, mortality, endocrine or exocrine insufficiency, length of stay, and health care utilization. Clinical resolution in 11 of 12 patients after DEN versus 3 of 12 step-up approach patients after PCD (P < 0.01). Nine step-up approach patients required surgery; 7 of these experienced complications. Direct endoscopic necrosectomy resulted in less ...
Digestive and Liver Disease, 2011
Aim: To evaluate the efficacy of step-up approach to infected necrotising pancreatitis. Methods: Retrospective analysis of 86 patients treated by step-up approach from 1989 to 2009. Infection was confirmed by examination of aspirated material or by presence of free pancreatic gas at contrastenhanced computed tomography. Conservative treatment was initially attempted in all patients; percutaneous catheter drainage was performed when conservative therapy failed; surgery was planned only if no clinical improvement was observed. Primary outcome was mortality. Results: Fifteen patients (17.4%) were successfully treated with conservative treatment only. Percutaneous catheter drainage was performed in 69 (80.2%). Eight patients (9.3%) died, two at week 1 without drainage or surgery and six after percutaneous catheter drainage and surgery. Eleven patients were converted to surgery (12.8%). Organ failure occurred in 59/86 (68.6%) and multiorgan failure in 25/86 (29.1%). Median (interquartile ranges) hospital stay and catheter dwell times were 13 (9-47) and 15 (7-34) days, respectively. There were 2.61 catheter problems and 1.68 catheter changes per patient. Conclusions: The step-up approach is an effective and safe strategy for the treatment of infected necrotising pancreatitis. Percutaneous drainage can avert the need for surgery in the majority of patients.
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.
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.
HPB, 2015
Background: The optimal diagnostic strategy and timing of intervention in infected necrotizing pancreatitis is subject to debate. We performed a survey on these topics amongst a group of international expert pancreatologists. Methods: An online survey including case vignettes was sent to 118 international pancreatologists. We evaluated the use and timing of fine needle aspiration (FNA), antibiotics, catheter drainage and (minimally invasive) necrosectomy. Results: The response rate was 74% (N = 87). None of the respondents use FNA routinely, 85% selectively and 15% never. Most respondents (87%) use a step-up approach in patients with infected necrosis. Walled-off necrosis (WON) is considered a prerequisite for endoscopic drainage and percutaneous drainage by 66% and 12%, respectively. After diagnosing infected necrosis, 55% routinely postpone invasive interventions, whereas 45% proceed immediately to intervention. Lack of consensus about timing of intervention was apparent on day 14 with proven infected necrosis (58% intervention vs. 42% non-invasive) as well as on day 20 with only clinically suspected infected necrosis (59% intervention vs. 41% non-invasive). Discussion: The step-up approach is the preferred treatment strategy in infected necrotizing pancreatitis amongst expert pancreatologists. There is no uniformity regarding the use of FNA and timing of intervention in the first 2-3 weeks of infected necrotizing pancreatitis.
The British journal of surgery, 2014
The aim of the study was to compare the outcomes of patients with pancreatic or peripancreatic walled-off necrosis by endoscopy using the conventional approach versus an algorithmic approach based on the collection size, location and stepwise response to intervention. This was an observational before-after study of consecutive patients managed over two time intervals. In the initial period (2004-2009) symptomatic patients with walled-off necrosis underwent conventional single transmural drainage with placement of two stents and a nasocystic catheter, followed by direct endoscopic necrosectomy, if required. In the later period (2010-2013) an algorithmic approach was adopted based on size and extent of the walled-off necrosis and stepwise response to intervention. The main outcome was treatment success, defined as a reduction in walled-off necrosis size to 2 cm or less on CT after 8 weeks. Forty-seven patients were treated in the first interval and 53 in the second. There was no diffe...