Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy
Primary Purpose
Periampullary Carcinoma, Pancreatic Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Omental Roll-up
Sponsored by
About this trial
This is an interventional treatment trial for Periampullary Carcinoma focused on measuring Pancreatoduodenectomy, Omentum, Wrapping, Roll-up, Whipple
Eligibility 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
Sites / Locations
- Paramin MuangkaewRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Omental Roll-up
No Omental Roll-up
Arm Description
Outcomes
Primary Outcome Measures
Complication rate after using omental roll-up technique
Complication rate after using omental roll-up technique compare with non-omental roll-up
Secondary Outcome Measures
Pancreatic fistula rate after using omental roll-up technique
Pancreatic fistula rate after using omental roll-up technique compare with non-omental roll-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03083938
Brief Title
Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy
Official Title
Prospective Randomized Controlled Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periampullary Carcinoma, Pancreatic Fistula
Keywords
Pancreatoduodenectomy, Omentum, Wrapping, Roll-up, Whipple
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omental Roll-up
Arm Type
Experimental
Arm Title
No Omental Roll-up
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Omental Roll-up
Intervention Description
Using omentum roll-up pancreato-jejunal anastomosis
Primary Outcome Measure Information:
Title
Complication rate after using omental roll-up technique
Description
Complication rate after using omental roll-up technique compare with non-omental roll-up
Time Frame
Within 30 days after surgery
Secondary Outcome Measure Information:
Title
Pancreatic fistula rate after using omental roll-up technique
Description
Pancreatic fistula rate after using omental roll-up technique compare with non-omental roll-up
Time Frame
Within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paramin Muangkaew, Doctor
Phone
+66860244424
Email
u4102064@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pongsatorn Tangtawee, Doctor
Phone
+66931959099
Email
pongsatorn.md@gmail.com
Facility Information:
Facility Name
Paramin Muangkaew
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paramin Muangkaew, Doctor
Phone
+66860244424
Email
u4102064@gmail.com
First Name & Middle Initial & Last Name & Degree
Pongsatorn Tangtawee, Doctor
Phone
+66931959099
Email
pongsatorn.md@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17254940
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. doi: 10.1016/j.jamcollsurg.2006.11.015. No abstract available.
Results Reference
background
PubMed Identifier
17116554
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. doi: 10.1016/j.jamcollsurg.2006.08.021. Epub 2006 Oct 25.
Results Reference
background
PubMed Identifier
25720806
Citation
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.
Results Reference
background
PubMed Identifier
22351908
Citation
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.
Results Reference
background
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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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