NCT03083938

Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy

Status unknown NA Last updated 29 August 2017

What this trial tests

NA trial testing Omental Roll-up in Periampullary Carcinoma in 60 participants. Status unknown.

Timeline

1 April 2017

Primary endpoint
1 April 2019

1 May 2019

Quick facts

Lead sponsor	Mahidol University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 April 2017
Primary completion	1 April 2019
Estimated completion	1 May 2019
Sites	1 location across Thailand

Drugs / interventions tested

• Omental Roll-up

Conditions studied

• Periampullary Carcinoma — all drugs for Periampullary Carcinoma →
• Pancreatic Fistula — all drugs for Pancreatic Fistula →

Sponsor

Mahidol University

Who can join

Adults 18 to 80, any sex, with Periampullary Carcinoma or Pancreatic Fistula. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at periampullary area, the morbidity and mortality rate with intra-abdominal collection, post pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately 50-60%. The causes of these complications usually come from post-operative pancreatic fistula. Nowadays, several methods have been reported to reduce the incidence of pancreatic fistula after undergoing pancreatoduodenectomy, such as pancreatic stenting, the use of intravenous somatostatin, the use of sealant material and wrapping anastomosis by soft tissue.

Wrapping pancreato-jejunal anastomosis with omentum is not a complicate procedure and requires no extra treatment expenses of the patient. It has been reported this technique has been applied in the non-randomized controlled trials and their data have significantly shown that the technique could reduce pancreatic fistula rate. Therefore, the researchers want to conduct an RCT study to compare complication rates between omental roll-up pancreato-jejunal anastomosis and non-omental roll-up groups.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prospective randomized controlled trial of omental roll-up technique on pancreatojejunostomy anastomosis for reducing perioperative complication in patients undergoing pancreatoduodenectomy.
   Tangtawee P, Mingphruedhi S, Rungsakulkij N, Suragul W, et al · · 2021 · cited 8× · PMID 33768697 · DOI 10.1002/jhbp.948