- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03083938
Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy
Prospective Randomized Controlled Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paramin Muangkaew, Doctor
- Phone Number: +66860244424
- Email: u4102064@gmail.com
Study Contact Backup
- Name: Pongsatorn Tangtawee, Doctor
- Phone Number: +66931959099
- Email: pongsatorn.md@gmail.com
Study Locations
-
-
-
Bangkok, Thailand, 10400
- Recruiting
- Paramin Muangkaew
-
Contact:
- Paramin Muangkaew, Doctor
- Phone Number: +66860244424
- Email: u4102064@gmail.com
-
Contact:
- Pongsatorn Tangtawee, Doctor
- Phone Number: +66931959099
- Email: pongsatorn.md@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Omental Roll-up
|
Using omentum roll-up pancreato-jejunal anastomosis
|
NO_INTERVENTION: No Omental Roll-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 30 days after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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. doi: 10.1016/j.jamcollsurg.2006.11.015. No abstract available.
- 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. doi: 10.1016/j.jamcollsurg.2006.08.021. Epub 2006 Oct 25.
- Ramia JM, de la Plaza R, Adel F, Ramiro C, Arteaga V, Garcia-Parreno 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID 12-59-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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