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

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ClinicalTrials.gov Identifier: NCT03083938
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Paramin Muangkaew, MD, Mahidol University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Periampullary Carcinoma Pancreatic Fistula Procedure: Omental Roll-up Not Applicable

Detailed Description:
This is a RCT study designed to compare the use of omental roll-up technique with non-omental roll-up technique at pancreato-jejunal anastomosis in patients undergoing pancreatoduodenectomy. The purpose of this study is to prove the hypothesis that omental roll-up technique can reduce the complication rate or pancratic fistula after pancreatoduodenectomy. This study was approved by the committee on human rights to conduct the research involving human subjects, faculty of medicine Ramathibodi hospital, Mahidol university. The patients are operated by experienced surgeons of Hepato-pancreato-biliary unit, department of surgery, Ramathibodi hospital and randomized into two groups by using the closed envelope method after completing pancreato-jejunal anastomosis. Then, patients are followed-up and the data are collected for 30 days after the surgery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Omental Roll-up Procedure: Omental Roll-up
Using omentum roll-up pancreato-jejunal anastomosis

No Intervention: No Omental Roll-up



Primary Outcome Measures :
  1. Complication rate after using omental roll-up technique [ Time Frame: Within 30 days after surgery ]
    Complication rate after using omental roll-up technique compare with non-omental roll-up


Secondary Outcome Measures :
  1. Pancreatic fistula rate after using omental roll-up technique [ Time Frame: Within 30 days after surgery ]
    Pancreatic fistula rate after using omental roll-up technique compare with non-omental roll-up



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing pancreatoduodenectomy from these disease, carcinoma at head of pancreas, carcinoma at ampullar of Vater, Distal cholangiocarcinoma, Carcinoma of duodenum

Exclusion Criteria:

  • Unresectable pancreatoduodenectomy
  • Patients underwent omentectomy from prior surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083938


Contacts
Contact: Paramin Muangkaew, Doctor +66860244424 u4102064@gmail.com
Contact: Pongsatorn Tangtawee, Doctor +66931959099 pongsatorn.md@gmail.com

Locations
Thailand
Paramin Muangkaew Recruiting
Bangkok, Thailand, 10400
Contact: Paramin Muangkaew, Doctor    +66860244424    u4102064@gmail.com   
Contact: Pongsatorn Tangtawee, Doctor    +66931959099    pongsatorn.md@gmail.com   
Sponsors and Collaborators
Mahidol University

Publications:
Responsible Party: Paramin Muangkaew, MD, Principal Investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT03083938     History of Changes
Other Study ID Numbers: ID 12-59-13
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paramin Muangkaew, MD, Mahidol University:
Pancreatoduodenectomy
Omentum
Wrapping
Roll-up
Whipple

Additional relevant MeSH terms:
Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases