1. Endoscopic transgastric vs surgical necrosectomy for infected necrotizing pancreatitis: a randomized trial
- Author
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Bakker, O.J., Santvoort, H.C. van, Brunschot, S. van, Geskus, R.B., Besselink, M.G., Bollen, T.L., Eijck, C.H. van, Fockens, P., Hazebroek, E.J., Nijmeijer, R.M., Poley, J.W., Ramshorst, B. van, Vleggaar, F.P., Boermeester, M.A., Gooszen, H.G., Weusten, B.L., Timmer, R., Goor, H. van, Surgery, RS: NUTRIM - R2 - Gut-liver homeostasis, Gastroenterology & Hepatology, Internal Medicine, Graduate School, AII - Amsterdam institute for Infection and Immunity, APH - Amsterdam Public Health, Epidemiology and Data Science, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA -Cancer Center Amsterdam, Gastroenterology and Hepatology, Other departments, and Radiology and Nuclear Medicine
- Subjects
Enterocutaneous fistula ,medicine.medical_specialty ,Percutaneous ,Pancreatic disease ,medicine.diagnostic_test ,business.industry ,General surgery ,medicine.medical_treatment ,Context (language use) ,General Medicine ,medicine.disease ,Surgery ,Endoscopy ,Pancreatic fistula ,Evaluation of complex medical interventions [NCEBP 2] ,Laparotomy ,medicine ,Pancreatitis ,Evaluation of complex medical interventions Tissue engineering and pathology [NCEBP 2] ,business - Abstract
Item does not contain fulltext 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.
- Published
- 2012
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