NCT03671031

Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Completed Last updated 25 September 2018

What this trial tests

trial testing isolated roux loop in Pancreatic Fistula in 109 participants. Completed in 30 June 2018.

Timeline

1 January 2009

Primary endpoint
30 June 2018

30 June 2018

Quick facts

Lead sponsor	Inonu University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	109
Start date	1 January 2009
Primary completion	30 June 2018
Estimated completion	30 June 2018
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• isolated roux loop
• single loop

Conditions studied

• Pancreatic Fistula — all drugs for Pancreatic Fistula →

Sponsor

Inonu University

Who can join

Eligibility, any sex, with Pancreatic Fistula. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.