Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

NCT03671031 | Completed

• 1 other identifier: 2018/16-22
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreaticoduodenectomy is a commonly applied operation for the treatment of benign and malignant diseases of periampullary region. Although recent progress in surgical techniques and medical care reduced the mortality rate of this operation below 5% in some institutes, the morbidity rate still remains high as 40-50% (1,2). Pancreatic anastomotic leaks and fistulas continue to be the main source of morbidity and mortality after pancreaticoduodenectomy. Although there are several recommended techniques to reduce the rate of pancreatic fistulas, optimal pancreatic reconstruction technique is still controversial (3-5). One of the recommended techniques for pancreatic reconstruction is isolated Roux loop pancreaticojejunostomy (6). With this method, as pancreatic anastomosis is kept away from biliary and gastric anastomoses, activation of the pancreatic enzyme precursors is blocked and in this way a reduction in the rate and severity of pancreatic fistula and also in the overall morbidity and mortality can be achieved (6-8). In this study, it is aimed to examine if isolated Roux loop pancreaticojejunostomy is superior to conventional pancreaticojejunostomy on postoperative outcomes.

Conditions

Pancreatic Fistula

Keywords

pancreatic fistula; pancreatic leak; whipple operation; roux-en-y

Outcome Measures

Primary Outcomes (1)

• Severity of postoperative pancreatic fistula

  Assessed according to International Study Group on Pancreatic Fistula definition

  1 week

Secondary Outcomes (5)

• Rate of postoperative pancreatic fistula

  1 week

• Operation time

  1 week

• Duration of hospital stay

  1 week

• Duration of intensive care unit stay

  1 week

• 30-day mortality

  1 week

Study Arms (2)

isolated roux loop

isolated roux loop reconstruction following pancreaticoduodenectomy as the first group.

Procedure: isolated roux loop

single loop

single loop reconstruction following pancreaticoduodenectomy as the second group.

Procedure: single loop

Interventions

isolated roux loop PROCEDURE

Isolated roux loop reconstruction following pancreaticoduodenectomy

isolated roux loop

single loop PROCEDURE

Conventional single loop reconstruction following pancreaticoduodenectomy

single loop

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who underwent pancreaticoduodenectomy at General Surgery Clinic in Inonu University between January 2009 and June 2018

You may qualify if:

• patients who underwent pancreaticoduodenectomy.

You may not qualify if:

• patients with missing data
• patients who underwent total pancreatectomy
• patients who had pancreaticogastrostomy as the reconstruction method
• patients who had emergency pancreaticoduodenectomy

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

Related Publications (8)

• Yang YM, Tian XD, Zhuang Y, Wang WM, Wan YL, Huang YT. Risk factors of pancreatic leakage after pancreaticoduodenectomy. World J Gastroenterol. 2005 Apr 28;11(16):2456-61. doi: 10.3748/wjg.v11.i16.2456.

  PMID: 15832417 BACKGROUND

• El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.

  PMID: 23494109 BACKGROUND

• Reid-Lombardo KM, Farnell MB, Crippa S, Barnett M, Maupin G, Bassi C, Traverso LW; Pancreatic Anastomotic Leak Study Group. Pancreatic anastomotic leakage after pancreaticoduodenectomy in 1,507 patients: a report from the Pancreatic Anastomotic Leak Study Group. J Gastrointest Surg. 2007 Nov;11(11):1451-8; discussion 1459. doi: 10.1007/s11605-007-0270-4. Epub 2007 Aug 21.

  PMID: 17710506 BACKGROUND

• Wente MN, Shrikhande SV, Muller MW, Diener MK, Seiler CM, Friess H, Buchler MW. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007 Feb;193(2):171-83. doi: 10.1016/j.amjsurg.2006.10.010.

  PMID: 17236843 BACKGROUND

• Xiong JJ, Altaf K, Mukherjee R, Huang W, Hu WM, Li A, Ke NW, Liu XB. Systematic review and meta-analysis of outcomes after intraoperative pancreatic duct stent placement during pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1050-61. doi: 10.1002/bjs.8788. Epub 2012 May 24.

  PMID: 22622664 BACKGROUND

• Machado MC, da Cunha JE, Bacchella T, Bove P. A modified technique for the reconstruction of the alimentary tract after pancreatoduodenectomy. Surg Gynecol Obstet. 1976 Aug;143(2):271-2.

  PMID: 941087 BACKGROUND

• Kingsnorth AN. Safety and function of isolated Roux loop pancreaticojejunostomy after Whipple's pancreaticoduodenectomy. Ann R Coll Surg Engl. 1994 May;76(3):175-9.

  PMID: 7912489 BACKGROUND

• Albertson DA. Pancreaticoduodenectomy with reconstruction by Roux-en-Y pancreaticojejunostomy: no operative mortality in a series of 25 cases. South Med J. 1994 Feb;87(2):197-201. doi: 10.1097/00007611-199402000-00010.

  PMID: 8115883 BACKGROUND

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Egemen Ozdemir, MD

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 14, 2018
• Study Start: January 1, 2009
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)