Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled 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...
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...
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.
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.
Cureus
Introduction Open necrosectomy in acute infected necrotizing pancreatitis is associated with very high mortality and morbidity. Moreover, if it is performed before four weeks, the benefits are limited. In this study, we evaluated the safety and efficacy of percutaneous catheter drainage (PCD) in patients with acute infected necrotizing pancreatitis. Methods It was a single-center, observational study, where all consecutive patients with proven or probable infected acute necrotizing pancreatitis in whom PCD was performed were studied. The patients who failed to respond to PCD underwent open necrosectomy. Baseline characteristics and the outcome of all included patients, including complications of PCD, were studied. Results A total of 46 patients (males=36, females=10) underwent PCD over a period of 18 months. Fifteen (32.60%) patients succumbed to their illness. PCD benefitted a total of 31 (67.39%) patients; in 17 (36.95%) patients, it worked as a standalone therapy, while in 14 (30.43%) patients, additional surgery was required where it helped to delay the surgery. Median days at which PCD and surgery were performed were 17.5 days (range: 2-28 days) and 33 days (range: 7-70 days), respectively. Lower mean arterial pressure at presentation, presence of multiorgan failure, more than 50% necrosis, higher baseline creatinine and bilirubin levels, and an early surgery were markers of increased mortality. Three (6.5%) patients had PCD-related complications, out of which only one required active intervention. Conclusion PCD in infected acute pancreatic necrosis is safe and effective. In one-third of the patients, it worked as standalone therapy, and in the rest it delayed the surgery beyond four weeks, thereby preventing the complications associated with early aggressive debridement.
British Journal of Surgery, 2011
Background: The role of percutaneous catheter drainage (PCD) in patients with (infected) necrotizing pancreatitis was evaluated. Methods: A systematic literature search was performed. Inclusion criteria were: consecutive cohort of patients with necrotizing pancreatitis undergoing PCD as primary treatment for peripancreatic collections; indication for PCD either (suspected) infected necrosis or symptomatic sterile pancreatic necrosis; and outcomes reported to include percentage of infected peripancreatic collections, need for additional surgical necrosectomy, complications and deaths. Exclusion criteria were: cohort of fewer than five patients; cohort included patients with chronic pancreatitis; selected subgroup of patients with acute pancreatitis studied, such as those with pseudocysts, pancreatic abscesses and/or exclusively sterile pancreatic necrosis; and cohort in which PCD was combined with another minimally invasive strategy and results for PCD alone not reported separately. Results: Eleven studies, including 384 patients, fulfilled the inclusion criteria. Only one study was a randomized controlled trial; most others were retrospective case series. Four studies reported on the presence of organ failure before PCD; this occurred in 67•2 per cent of 116 patients. Infected necrosis was proven in 271 (70•6 per cent) of 384 patients. No additional surgical necrosectomy was required after PCD in 214 (55•7 per cent) of 384 patients. Complications consisted mostly of internal and external pancreatic fistulas. The overall mortality rate was 17•4 per cent (67 of 384 patients). Nine of 11 studies reported mortality separately for patients with infected necrosis undergoing PCD; the mortality rate in this group was 15•4 per cent (27 of 175). Conclusion: A considerable number of patients can be treated with PCD without the need for surgical necrosectomy.
Improving the Outcome of Acute Pancreatitis
Digestive diseases (Basel, Switzerland), 2016
Acute pancreatitis (AP) is the most common indication for hospital admission and its incidence is rising. It has a variable prognosis, which is mainly dependent upon the development of persistent organ failure and infected necrotizing pancreatitis. In the past few years, based on large-scale multicenter randomized trials, some novel insights regarding clinical management have emerged. In patients with infected pancreatic necrosis, a step-up approach of percutaneous catheter drainage followed by necrosectomy only when the patient does not improve, reduces new-onset organ failure and prevents the need for necrosectomy in about a third of patients. A randomized pilot study comparing surgical to endoscopic necrosectomy in patients with infected necrotizing pancreatitis showed a striking reduction of the pro-inflammatory response following endoscopic necrosectomy. These promising results have recently been tested in a large multicenter randomized trial whose results are eagerly awaited. ...
Annals of Intensive Care
Background Recent guidelines advocate a step-up approach for managing suspected infected pancreatic necrosis (IPN) during acute pancreatitis. Nearly half the patients require secondary necrosectomy after catheter drainage. Our primary objective was to assess the external validity of a previously reported nomogram for catheter drainage, based on four predictors of failure. Our secondary objectives were to identify other potential predictors of catheter-drainage failure. We retrospectively studied consecutive patients admitted to the intensive care units (ICUs) of three university hospitals in France between 2012 and 2016, for severe acute pancreatitis with suspected IPN requiring catheter drainage. We assessed drainage success and failure rates in 72 patients, with success defined as survival without subsequent necrosectomy and failure as death and/or subsequent necrosectomy required by inadequate improvement. We plotted the receiver operating characteristics (ROC) curve for the nomo...