Pancreaticogastrostomy Versus Pancreaticojejunostomy With Dunking Technique After Pancreaticodudenectomy: A Prospective Randomized Comparative Study
1 other identifier
observational
40
0 countries
N/A
Brief Summary
To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy in the treatment of operable periampullary malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2021
CompletedFirst Posted
Study publicly available on registry
December 28, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedDecember 28, 2021
December 1, 2021
1 year
December 10, 2021
December 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of postoperative anastomosis leakage
Compare between dunking in pancreaticogastrostomy and pancreaticojejunostomy and the rate of postoperative anastomosis leakage
One month
Study Arms (2)
Pancreaticojejunostomy
With Dunking Technique after Pancreaticodudenectomy
Pancreaticogastrostomy
With Dunking Technique after Pancreaticodudenectomy
Interventions
To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy
Eligibility Criteria
All cases of resectable periampullary carcinomas
You may qualify if:
- All cases of resectable periampullary carcinomas (cancer head of pancreas, ampullary carcinoma, distal cholangiocarcinoma and second part of duodenum adenocarcinoma) that are surgically fit according to ASA.
You may not qualify if:
- \. Surgically unfit cases according to ASA 2. Locally advanced irresectable cases
- Abutment or encasement of coeliac trunk
- Encasement of SMA less than 180 degree of its axis
- Encasement of portal/SMV more than 180 degree of its axis or infiltration segment too long more than 2.5 cm that the remaining segment will not coapts after resection.
- \. Metastatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Cheng Y, Briarava M, Lai M, Wang X, Tu B, Cheng N, Gong J, Yuan Y, Pilati P, Mocellin S. Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD012257. doi: 10.1002/14651858.CD012257.pub2.
PMID: 28898386BACKGROUNDQue W, Fang H, Yan B, Li J, Guo W, Zhai W, Zhang S. Pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy: a meta-analysis of randomized controlled trials. Am J Surg. 2015 Jun;209(6):1074-82. doi: 10.1016/j.amjsurg.2014.07.019. Epub 2015 Jan 22.
PMID: 25743406BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident doctor
Study Record Dates
First Submitted
December 10, 2021
First Posted
December 28, 2021
Study Start
March 1, 2022
Primary Completion
March 1, 2023
Study Completion
April 1, 2023
Last Updated
December 28, 2021
Record last verified: 2021-12