RCTs in der Pankreaschirurgie der letzten 10 Jahre – ein Update

Zusammenfassung

Randomisiert kontrollierte Studien (RCT) stellen eine der wichtigsten Quellen neuer Evidenz für die Behandlung insbesondere onkologischer Patienten dar. Insbesondere auf dem Gebiet der Pankreaschirurgie, wo Komplikationen vergleichsweise häufig und schwerwiegend sind, sind innovative operativ-technische wie auch periinterventionelle Innovationen gefragt, die in der Lage sind, Morbidität und Mortalität zu reduzieren. Trotz der mannigfaltigen methodischen Herausforderungen bei der Durchführung chirurgischer RCTs konnten in den letzten 10 Jahren große und wissenschaftlich hochwertige Studien verzeichnet werden.

Dieser Review gibt einen Überblick über wichtige, bereits abgeschlossene und publizierte, aber auch über interessante und wichtige ausstehende RCTs in der Pankreaschirurgie.

Abstract

This review provides a summary of important, completed and published clinical trials, together with interesting and important running RCTs in pancreatic surgery.

Randomised controlled studies (RCT) are one of the most important sources of new evidence for the treatment of cancer patients. This is particularly the case for pancreas surgery, where complications are comparatively common and serious and innovative surgical techniques and peri-interventional innovations are needed that could reduce morbidity and mortality. Although there are many very different methodological challenges in performing surgical RCTs, large surgical RCTs of high scientific quality have been completed during the last 10 years.

Schlüsselwörter

randomisiert kontrollierte Studie - Pankreaschirurgie - Viszeralchirurgie - chirurgische Verfahren - evidenzbasierte Medizin

Keywords

randomized controlled trial - pancreatic surgery - abdominal surgery - surgical procedures - evidence-based medicine

• Literatur

• 1 Seiler CM, Diener MK, Schuhmacher C. Impact of clinical trials for surgery. Chirurg 2010; 81: 334-340
• 2 Bray F, Ferlay J, Soerjomataram I. et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018; 68: 394-424
• 3 Rahib L, Smith BD, Aizenberg R. et al. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res 2014; 74: 2913-2921
• 4 Ducreux M, Cuhna AS, Caramella C. et al. Cancer of the pancreas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2015; 26 (Suppl. 05) v56-v68
• 5 Lillemoe KD, Kaushal S, Cameron JL. et al. Distal pancreatectomy: indications and outcomes in 235 patients. Ann Surg 1999; 229: 693-698
• 6 McMillan MT, Christein JD, Callery MP. et al. Comparing the burden of pancreatic fistulas after pancreatoduodenectomy and distal pancreatectomy. Surgery 2016; 159: 1013-1022
• 7 Bassi C, Marchegiani G, Dervenis C. et al. The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery 2017; 161: 584-591
• 8 Knaebel HP, Diener MK, Wente MN. et al. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg 2005; 92: 539-546
• 9 Diener MK, Seiler CM, Rossion I. et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet 2011; 377: 1514-1522
• 10 Iannitti DA, Coburn NG, Somberg J. et al. Use of the round ligament of the liver to decrease pancreatic fistulas: a novel technique. J Am Coll Surg 2006; 203: 857-864
• 11 Hassenpflug M, Hartwig W, Strobel O. et al. Decrease in clinically relevant pancreatic fistula by coverage of the pancreatic remnant after distal pancreatectomy. Surgery 2012; 152: S164-S171
• 12 Hassenpflug M, Hinz U, Strobel O. et al. Teres Ligament Patch Reduces Relevant Morbidity After Distal Pancreatectomy (the DISCOVER Randomized Controlled Trial). Ann Surg 2016; 264: 723-730
• 13 Wente MN, Shrikhande SV, Muller MW. et al. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg 2007; 193: 171-183
• 14 Wente MN, Veit JA, Bassi C. et al. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery 2007; 142: 20-25
• 15 Keck T, Wellner UF, Bahra M. et al. Pancreatogastrostomy Versus Pancreatojejunostomy for RECOnstruction After PANCreatoduodenectomy (RECOPANC, DRKS 00000767): Perioperative and Long-term Results of a Multicenter Randomized Controlled Trial. Ann Surg 2016; 263: 440-449
• 16 Zhang HY, Zhao CL, Xie J. et al. To drain or not to drain in colorectal anastomosis: a meta-analysis. Int J Colorectal Dis 2016; 31: 951-960
• 17 Wang Z, Chen J, Su K. et al. Abdominal drainage versus no drainage post-gastrectomy for gastric cancer. Cochrane Database Syst Rev 2015; (05) CD008788
• 18 Gurusamy KS, Koti R, Davidson BR. Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev 2013; (09) CD006004
• 19 Haane C, Mardin WA, Schmitz B. et al. Pancreatoduodenectomy--current status of surgical and perioperative techniques in Germany. Langenbecks Arch Surg 2013; 398: 1097-1105
• 20 Van Buren 2nd G, Bloomston M, Hughes SJ. et al. A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. Ann Surg 2014; 259: 605-612
• 21 Conlon KC, Labow D, Leung D. et al. Prospective randomized clinical trial of the value of intraperitoneal drainage after pancreatic resection. Ann Surg 2001; 234: 487-493
• 22 Witzigmann H, Diener MK, Kienkotter S. et al. No Need for Routine Drainage After Pancreatic Head Resection: The Dual-Center, Randomized, Controlled PANDRA Trial (ISRCTN04937707). Ann Surg 2016; 264: 528-537
• 23 Zhang W, He S, Cheng Y. et al. Prophylactic abdominal drainage for pancreatic surgery. Cochrane Database Syst Rev 2018; (06) CD010583
• 24 Kaiser J, Niesen W, Probst P. et al. Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial. Trials 2019; 20: 332
• 25 Eisenberg JD, Rosato EL, Lavu H. et al. Delayed Gastric Emptying After Pancreaticoduodenectomy: an Analysis of Risk Factors and Cost. J Gastrointest Surg 2015; 19: 1572-1580
• 26 Diener MK, Knaebel HP, Heukaufer C. et al. A systematic review and meta-analysis of pylorus-preserving versus classical pancreaticoduodenectomy for surgical treatment of periampullary and pancreatic carcinoma. Ann Surg 2007; 245: 187-200
• 27 Hackert T, Probst P, Knebel P. et al. Pylorus Resection Does Not Reduce Delayed Gastric Emptying After Partial Pancreatoduodenectomy: A Blinded Randomized Controlled Trial (PROPP Study, DRKS00004191). Ann Surg 2018; 267: 1021-1027
• 28 Wente MN, Bassi C, Dervenis C. et al. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery 2007; 142: 761-768
• 29 Matsumoto I, Shinzeki M, Asari S. et al. A prospective randomized comparison between pylorus- and subtotal stomach-preserving pancreatoduodenectomy on postoperative delayed gastric emptying occurrence and long-term nutritional status. J Surg Oncol 2014; 109: 690-696
• 30 Kawai M, Tani M, Hirono S. et al. Pylorus ring resection reduces delayed gastric emptying in patients undergoing pancreatoduodenectomy: a prospective, randomized, controlled trial of pylorus-resecting versus pylorus-preserving pancreatoduodenectomy. Ann Surg 2011; 253: 495-501
• 31 Toyama H, Matsumoto I, Mizumoto T. et al. Influence of the Retrocolic Versus Antecolic Route for Alimentary Tract Reconstruction on Delayed Gastric Emptying After Pancreatoduodenectomy: A Multicenter, Noninferiority Randomized Controlled Trial. Ann Surg 2021; 274: 935-944
• 32 Eshuis WJ, van Eijck CH, Gerhards MF. et al. Antecolic versus retrocolic route of the gastroenteric anastomosis after pancreatoduodenectomy: a randomized controlled trial. Ann Surg 2014; 259: 45-51
• 33 Ahmed Ali U, Pahlplatz JM, Nealon WH. et al. Endoscopic or surgical intervention for painful obstructive chronic pancreatitis. Cochrane Database Syst Rev 2015; (03) CD007884
• 34 Diener MK, Rahbari NN, Fischer L. et al. Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for surgical treatment of chronic pancreatitis: a systematic review and meta-analysis. Ann Surg 2008; 247: 950-961
• 35 Diener MK, Huttner FJ, Kieser M. et al. Partial pancreatoduodenectomy versus duodenum-preserving pancreatic head resection in chronic pancreatitis: the multicentre, randomised, controlled, double-blind ChroPac trial. Lancet 2017; 390: 1027-1037
• 36 Aaronson NK, Ahmedzai S, Bergman B. et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365-376
• 37 Gurusamy KS, Lusuku C, Halkias C. et al. Duodenum-preserving pancreatic resection versus pancreaticoduodenectomy for chronic pancreatitis. Cochrane Database Syst Rev 2016; (02) CD011521
• 38 Ke N, Jia D, Huang W. et al. Earlier surgery improves outcomes from painful chronic pancreatitis. Medicine (Baltimore) 2018; 97: e0651
• 39 Issa Y, Kempeneers MA, Bruno MJ. et al. Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis: The ESCAPE Randomized Clinical Trial. JAMA 2020; 323: 237-247
• 40 Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg 2002; 183: 630-641
• 41 Klotz R, Larmann J, Klose C. et al. Gastrointestinal Complications After Pancreatoduodenectomy With Epidural vs Patient-Controlled Intravenous Analgesia: A Randomized Clinical Trial. JAMA Surg 2020; 155: e200794
• 42 Pratt WB, Steinbrook RA, Maithel SK. et al. Epidural analgesia for pancreatoduodenectomy: a critical appraisal. J Gastrointest Surg 2008; 12: 1207-1220
• 43 Nickel F, Haney CM, Kowalewski KF. et al. Laparoscopic Versus Open Pancreaticoduodenectomy: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ann Surg 2020; 271: 54-66
• 44 van Hilst J, de Rooij T, Bosscha K. et al. Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): a multicentre, patient-blinded, randomised controlled phase 2/3 trial. Lancet Gastroenterol Hepatol 2019; 4: 199-207
• 45 Wang M, Li D, Chen R. et al. Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours: a multicentre, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol 2021; 6: 438-447
• 46 de Rooij T, van Hilst J, van Santvoort H. et al. Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD): A Multicenter Patient-blinded Randomized Controlled Trial. Ann Surg 2019; 269: 2-9
• 47 Klotz R, Doerr-Harim C, Ahmed A. et al. Top ten research priorities for pancreatic cancer therapy. Lancet Oncol 2020; 21: e295-e296