Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Completed

• Conditions: Pancreatic Fistula
• Interventions: Procedure: isolated roux loop; Procedure: single loop

• Registration Number: NCT03671031
• Lead Sponsor: Inonu University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2018-09
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Last Update Submitted: 2018-09-23
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• patients who underwent pancreaticoduodenectomy.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
isolated roux loop	isolated roux loop	isolated roux loop reconstruction following pancreaticoduodenectomy as the first group.
single loop	single loop	single loop reconstruction following pancreaticoduodenectomy as the second group.

Primary Outcome Measures

Name	Time	Method
Severity of postoperative pancreatic fistula	1 week	Assessed according to International Study Group on Pancreatic Fistula definition

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	1 week	in days
Operation time	1 week	in minutes
Rate of postoperative pancreatic fistula	1 week	Number of participants with postoperative pancreatic fistula
Duration of intensive care unit stay	1 week	in days
30-day mortality	1 week	Number of participants died in 30 days after operation

Trial Locations

Locations (1)

Inonu University; 🇹🇷 Malatya, Turkey