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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03083938
Other study ID # ID 12-59-13
Secondary ID
Status Recruiting
Phase N/A
First received March 14, 2017
Last updated August 28, 2017
Start date April 1, 2017
Est. completion date May 1, 2019

Study information

Verified date August 2017
Source Mahidol University
Contact Paramin Muangkaew, Doctor
Phone +66860244424
Email u4102064@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Omental Roll-up
Using omentum roll-up pancreato-jejunal anastomosis

Locations

Country Name City State
Thailand Paramin Muangkaew Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Choi SB, Lee JS, Kim WB, Song TJ, Suh SO, Choi SY. Efficacy of the omental roll-up technique in pancreaticojejunostomy as a strategy to prevent pancreatic fistula after pancreaticoduodenectomy. Arch Surg. 2012 Feb;147(2):145-50. doi: 10.1001/archsurg.2011.865. — View Citation

Iannitti DA, Coburn NG, Somberg J, Ryder BA, Monchik J, Cioffi WG. Use of the round ligament of the liver to decrease pancreatic fistulas: a novel technique. J Am Coll Surg. 2006 Dec;203(6):857-64. Epub 2006 Oct 25. — View Citation

Ramia JM, de la Plaza R, Adel F, Ramiro C, Arteaga V, Garcia-Parreño J. Wrapping in pancreatic surgery: a systematic review. ANZ J Surg. 2014 Dec;84(12):921-4. doi: 10.1111/ans.12491. Epub 2013 Dec 19. Review. — View Citation

Sakamoto Y, Shimada K, Esaki M, Kajiwara T, Sano T, Kosuge T. Wrapping the stump of the gastroduodenal artery using the falciform ligament during pancreaticoduodenectomy. J Am Coll Surg. 2007 Feb;204(2):334-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Complication rate after using omental roll-up technique Complication rate after using omental roll-up technique compare with non-omental roll-up Within 30 days after surgery
Secondary Pancreatic fistula rate after using omental roll-up technique Pancreatic fistula rate after using omental roll-up technique compare with non-omental roll-up Within 30 days after surgery
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