Antecolic Versus Retrocolic Gastrojejunostomy During Whipple's Procedure
1 other identifier
interventional
76
1 country
1
Brief Summary
Aim: This randomized clinical study aims to compare occurrence of DGE in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy. Methods: Participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the Surgical Department of the University Hospital of Larissa. Patients will be randomized to undergo either an antecolic or a retrocolic gastrojejunostomy and the occurrence of DGE will then be compared between the two groups. Individuals younger than 18 or older than 75 years old, as well as patients who do not consent to participate in this trial, will be excluded. Expected results: Based on available literature, antecolic gastrojejunostomy may be related with a lower incidence of DGE, without a statistically significant difference between the two methods. We aim to show if one of the two methods of gastrointestinal reconstruction (antecolic versus retrocolic) affects DGE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
1 active site
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
March 30, 2025
CompletedStudy Start
First participant enrolled
March 30, 2025
CompletedFirst Posted
Study publicly available on registry
April 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
June 6, 2025
March 1, 2025
3 years
March 30, 2025
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delayed Gastric Emptying
The occurence of delayed gastric emptying will be compared between two groups of patients: those who undergo an antecolic gastrojejunostomy and those who undergo a retrocolic approach.
3 years
Study Arms (2)
Antecolic gastrojejunostomy
ACTIVE COMPARATORRetrocolic gastrojejunostomy
ACTIVE COMPARATORInterventions
Gastrojejunostomy in front of the transverse colon
Gastrojejunostomy through the transverse mesocolon
Eligibility Criteria
You may qualify if:
- Age over 18 years old
- Elective pancreaticoduodenectomy
- Signed consent form
You may not qualify if:
- Age under 18 years old
- Patients who are participants in other trials that may affect the results of this study
- Patients who do not consent to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Thessaly
Larissa, 41500, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dimitrios Symeonidis
University of Thessaly
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Msc
Study Record Dates
First Submitted
March 30, 2025
First Posted
April 6, 2025
Study Start
March 30, 2025
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2029
Last Updated
June 6, 2025
Record last verified: 2025-03