Endoscopic Transgastric vs Surgical Necrosectomy for Infected Necrotizing Pancreatitis: A Randomized Trial

• Published in: JAMA : the journal of the American Medical Association 2012-03, Vol.307 (10), p.1053-1061
• Main Authors: Bakker, Olaf J, van Santvoort, Hjalmar C, van Brunschot, Sandra, Geskus, Ronald B, Besselink, Marc G, Bollen, Thomas L, van Eijck, Casper H, Fockens, Paul, Hazebroek, Eric J, Nijmeijer, Rian M, Poley, Jan-Werner, van Ramshorst, Bert, Vleggaar, Frank P, Boermeester, Marja A, Gooszen, Hein G, Weusten, Bas L, Timmer, Robin, Dutch Pancreatitis Study Group, for the
• Format: Article
• Language: English
• Subjects: Aged; Biological and medical sciences; Biomarkers - blood; Capsule Endoscopy; Clinical outcomes; Clinical trials; complications; composite materials; Diagnostic tests; Drainage; Female; Gastroenterology. Liver. Pancreas. Abdomen; General aspects; Hospitals; Humans; Infection - complications; Inflammation - prevention & control; Interleukin-6 - blood; intervention; Laparotomy; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; medical instruments; Medical sciences; Middle Aged; Natural Orifice Endoscopic Surgery - methods; Organs; Other diseases. Semiology; Pancreas; Pancreatitis, Acute Necrotizing - complications; Pancreatitis, Acute Necrotizing - surgery; Postoperative Complications - prevention & control; surgery; Surgical techniques; Treatment Outcome
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.2012.276

CONTEXT Most patients with infected necrotizing pancreatitis require necrosectomy. Surgical necrosectomy induces a proinflammatory response and is associated with a high complication rate. Endoscopic transgastric necrosectomy, a form of natural orifice transluminal endoscopic surgery, may reduce the proinflammatory response and reduce complications. OBJECTIVE To compare the proinflammatory response and clinical outcome of endoscopic transgastric and surgical necrosectomy. DESIGN, SETTING, AND PATIENTS Randomized controlled assessor-blinded clinical trial in 3 academic hospitals and 1 regional teaching hospital in the Netherlands between August 20, 2008, and March 3, 2010. Patients had signs of infected necrotizing pancreatitis and an indication for intervention. INTERVENTIONS Random allocation to endoscopic transgastric or surgical necrosectomy. Endoscopic necrosectomy consisted of transgastric puncture, balloon dilatation, retroperitoneal drainage, and necrosectomy. Surgical necrosectomy consisted of video-assisted retroperitoneal debridement or, if not feasible, laparotomy. MAIN OUTCOME MEASURES The primary end point was the postprocedural proinflammatory response as measured by serum interleukin 6 (IL-6) levels. Secondary clinical end points included a predefined composite end point of major complications (new-onset multiple organ failure, intra-abdominal bleeding, enterocutaneous fistula, or pancreatic fistula) or death. RESULTS We randomized 22 patients, 2 of whom did not undergo necrosectomy following percutaneous catheter drainage and could not be analyzed for the primary end point. Endoscopic transgastric necrosectomy reduced the postprocedural IL-6 levels compared with surgical necrosectomy (P = .004). The composite clinical end point occurred less often after endoscopic necrosectomy (20% vs 80%; risk difference [RD], 0.60; 95% CI, 0.16-0.80; P = .03). Endoscopic necrosectomy did not cause new-onset multiple organ failure (0% vs 50%, RD, 0.50; 95% CI, 0.12-0.76; P = .03) and reduced the number of pancreatic fistulas (10% vs 70%; RD, 0.60; 95% CI, 0.17-0.81; P = .02). CONCLUSION In patients with infected necrotizing pancreatitis, endoscopic necrosectomy reduced the proinflammatory response as well as the composite clinical end point compared with surgical necrosectomy. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN07091918