CC BY-NC-ND 4.0 · Endosc Int Open 2017; 05(09): E798-E808
DOI: 10.1055/s-0043-110565
Original article
Eigentümer und Copyright ©Georg Thieme Verlag KG 2017

Preoperative biliary drainage by plastic or self-expandable metal stents in patients with periampullary tumors: results of a randomized clinical study

Greger Olsson
1   Centre for Digestive Diseases, Karolinska University Hospital and Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden
2   Department of Surgery, Highland Hospital, Eksjö, Sweden
,
Farshad Frozanpor
3   Department of Surgery, Danderyd Hospital, Stockholm, Sweden
,
Lars Lundell
1   Centre for Digestive Diseases, Karolinska University Hospital and Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden
,
Lars Enochsson
1   Centre for Digestive Diseases, Karolinska University Hospital and Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden
,
Christoph Ansorge
1   Centre for Digestive Diseases, Karolinska University Hospital and Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden
,
Marco Del Chiaro
1   Centre for Digestive Diseases, Karolinska University Hospital and Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden
,
Marcus Reuterwall-Hansson
1   Centre for Digestive Diseases, Karolinska University Hospital and Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden
,
Alysha Shetye
1   Centre for Digestive Diseases, Karolinska University Hospital and Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden
,
Urban Arnelo
1   Centre for Digestive Diseases, Karolinska University Hospital and Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden
› Author Affiliations
Further Information

Publication History

submitted 15 December 2016

accepted after revision 15 March 2017

Publication Date:
05 September 2017 (online)

Abstract

Background and study aims Preoperative biliary drainage in patients with periampullary tumors and jaundice has been popularized to improve the quality of life and minimize the risks associated with subsequent radical surgery. The aim of this study was to investigate the possible superiority of self-expandable metal stents (SEMS) over plastic stents, by comparing the amount of bacteria in intraoperatively collected bile and using this variable as a proxy for the efficacy of the respective biliary drainage modalities.

Patients and methods In this randomized clinical trial, 92 patients with obstructive jaundice were enrolled; 45 were allocated to the plastic stent group and 47 to the SEMS group. The primary outcome was the extent and magnitude of biliary bacterial growth at the time of surgical exploration. Secondary outcomes were: macroscopic grading of inflammation of the stented bile ducts, occurrence of adverse events after stenting, stent dysfunction, recognized surgical complexities, and incidence of postoperative complications.

Results The patients were well matched regarding clinical and disease-specific characteristics. At surgery, there were no group differences in the bacterial amount and composition of the bile cultures or the perceived difficulty of surgical dissection. During the preoperative biliary drainage period, more instances of stent dysfunction requiring stent replacement were recorded in the plastic stent group (19 % vs. 0 %; P = 0.03). Postoperative complications in patients who underwent curative surgery were more common in patients with plastic stents (72 % vs. 52 %), among which clinically significant leakage from the pancreatic anastomoses seemed to predominate (12 % vs. 3.7 %); however, none of these differences in postoperative adverse events reached statistical significance.

Conclusion This randomized clinical study was unable to demonstrate any superiority of SEMS in the efficacy of preoperative bile drainage, as assessed by the amount of bacteria in the intraoperatively collected bile. However, some data in favor of SEMS were observed among the clinical secondary outcomes variables (preoperative stent exchange rates) without increases in local inflammatory reactions.

Trial registered at ClinicalTrials.gov (NCT00501176).

 
  • References

  • 1 Bonin EA, Baron TH. Preoperative biliary stents in pancreatic cancer. J Hepatobiliary Pancreat Sci 2011; 18: 621-629
  • 2 Kloek JJ, Heger M, van der Gaag NA. et al. Effect of preoperative biliary drainage on coagulation and fibrinolysis in severe obstructive cholestasis. J Clin Gastroenterol 2010; 44: 646-652
  • 3 Sewnath ME, Birjmohun RS, Rauws EA. et al. The effect of preoperative biliary drainage on postoperative complications after pancreaticoduodenectomy. J Am Coll Surg 2001; 192: 726-734
  • 4 Smith RA, Dajani K, Dodd S. et al. Preoperative resolution of jaundice following biliary stenting predicts more favourable early survival in resected pancreatic ductal adenocarcinoma. Ann Surg Oncol 2008; 15: 3138-3146
  • 5 Velanovich V, Kheibek T, Khan M. Relationship of postoperative complications from preoperative biliary stents after pancreaticoduodenectomy. A new cohort analysis and meta-analysis of modern studies. JOP 2009; 10: 24-29
  • 6 Fang Y, Gurusamy KS, Wang Q. et al. Pre-operative biliary drainage for obstructive jaundice. Cochrane Database Syst Rev 2012; 9: CD005444
  • 7 Fang Y, Gurusamy KS, Wang Q. et al. Meta-analysis of randomized clinical trials on safety and efficacy of biliary drainage before surgery for obstructive jaundice. Br J Surg 2013; 100: 1589-1596
  • 8 Hatfield AR, Tobias R, Terblanche J. et al. Preoperative external biliary drainage in obstructive jaundice. A prospective controlled clinical trial. Lancet 1982; 2: 896-899
  • 9 Lai EC, Lau SH, Lau WY. The current status of preoperative biliary drainage for patients who receive pancreaticoduodenectomy for periampullary carcinoma: a comprehensive review. Surgeon 2014; 12: 290-296
  • 10 Mezhir JJ, Brennan MF, Baser RE. et al. A matched case-control study of preoperative biliary drainage in patients with pancreatic adenocarcinoma: routine drainage is not justified. J Gastrointest Surg 2009; 13: 2163-2169
  • 11 Povoski SP, Karpeh Jr MS, Conlon KC. et al. Association of preoperative biliary drainage with postoperative outcome following pancreaticoduodenectomy. Ann Surg 1999; 230: 131-142
  • 12 Sewnath ME, Karsten TM, Prins MH. et al. A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice. Ann Surg 2002; 236: 17-27
  • 13 Sivaraj SM, Vimalraj V, Saravanaboopathy P. et al. Is bactibilia a predictor of poor outcome of pancreaticoduodenectomy?. Hepatobiliary Pancreatic Dis Int 2010; 9: 65-68
  • 14 Sohn TA, Yeo CJ, Cameron JL. et al. Do preoperative biliary stents increase postpancreaticoduodenectomy complications?. J Gastrointest Surg 2000; 4: 258-567
  • 15 Tol JA, van Hooft JE, Timmer R. et al. Metal or plastic stents for preoperative biliary drainage in resectable pancreatic cancer. Gut 2016; 65: 1981-1987
  • 16 van der Gaag NA, Rauws EA, van Eijck CH. et al. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med 2010; 362: 129-137
  • 17 Aadam AA, Evans DB, Khan A. et al. Efficacy and safety of self-expandable metal stents for biliary decompression in patients receiving neoadjuvant therapy for pancreatic cancer: a prospective study. Gastrointest Endosc 2012; 76: 67-75
  • 18 Jagannath P, Dhir V, Shrikhande S. et al. Effect of preoperative biliary stenting on immediate outcome after pancreaticoduodenectomy. Br J Surg 2005; 92: 356-361
  • 19 Sahora K, Morales-Oyarvide V, Ferrone C. et al. Preoperative biliary drainage does not increase major complications in pancreaticoduodenectomy: a large single center experience from the Massachusetts General Hospital. J Hepatobiliary Pancreat Sci 2016; 23: 181-187
  • 20 Davids PH, Groen AK, Rauws EA. et al. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet 1992; 340: 1488-1492
  • 21 Kaassis M, Boyer J, Dumas R. et al. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. Gastrointest Endosc 2003; 57: 178-182
  • 22 Moses PL, Alnaamani KM, Barkun AN. et al. Randomized trial in malignant biliary obstruction: plastic vs partially covered metal stents. World J Gastroenterol 2013; 19: 8638-8646
  • 23 Prat F, Chapat O, Ducot B. et al. A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc 1998; 47: 1-7
  • 24 Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc 2006; 63: 986-995
  • 25 Ahmad J, Siqueira E, Martin J. et al. Effectiveness of the Ultraflex Diamond stent for the palliation of malignant biliary obstruction. Endoscopy 2002; 34: 793-796
  • 26 Ferlitsch A, Oesterreicher C, Dumonceau JM. et al. Diamond stents for palliation of malignant bile duct obstruction: a prospective multicenter evaluation. Endoscopy 2001; 33: 645-650
  • 27 Cavell LK, Allen PJ, Vinoya C. et al. Biliary self-expandable metal stents do not adversely affect pancreaticoduodenectomy. Am J Gastroenterol 2013; 108: 1168-1173
  • 28 Lawrence C, Howell DA, Conklin DE. et al. Delayed pancreaticoduodenectomy for cancer patients with prior ERCP-placed, nonforeshortening, self-expanding metal stents: a positive outcome. Gastrointest Endosc 2006; 63: 804-807
  • 29 Wasan SM, Ross WA, Staerkel GA. et al. Use of expandable metallic biliary stents in resectable pancreatic cancer. Am J Gastroenterol 2005; 100: 2056-2061
  • 30 Takada T, Strasberg SM, Solomkin JS. et al. TG13: Updated Tokyo guidelines for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci 2013; 20: 1-7
  • 31 Cotton PB, Lehman G, Vennes J. et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
  • 32 Bassi C, Dervenis C, Butturini G. et al. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery 2005; 138: 8-13
  • 33 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
  • 34 Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240: 205-213
  • 35 Sun C, Yan G, Li Z. et al. A meta-analysis of the effect of preoperative biliary stenting on patients with obstructive jaundice. Medicine 2014; 93: e189
  • 36 Lermite E, Pessaux P, Teyssedou C. et al. Effect of preoperative endoscopic biliary drainage on infectious morbidity after pancreatoduodenectomy: a case-control study. Am J Surg 2008; 195: 442-446
  • 37 Kahaleh M, Tokar J, Le T. et al. Removal of self-expandable metallic Wallstents. Gastrointest Endosc 2004; 60: 640-644
  • 38 Petersen BT. SEMS removal: salvage technique or new paradigms. Gastrointest Endosc 2005; 62: 911-913
  • 39 Cote GA, Kumar N, Ansstas M. et al. Risk of post-ERCP pancreatitis with placement of self-expandable metallic stents. Gastrointest Endosc 2010; 72: 748-754
  • 40 Mullen JT, Lee JH, Gomez HF. et al. Pancreaticoduodenectomy after placement of endobiliary metal stents. J Gastrointest Surg 2005; 9: 1094-1104