- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06914349
Antecolic Versus Retrocolic Gastrojejunostomy During Whipple's Procedure
Antecolic Versus Retrocolic Gastrojejunostomy Following Pancreaticoduodenectomy: a Prospective Randomised Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chrysoula C Kolla
- Phone Number: +306983075706
- Email: christinakolla@yahoo.gr
Study Locations
-
-
-
Larissa, Greece, 41500
- Recruiting
- University of Thessaly
-
Contact:
- Chrysoula-Christina Kolla
- Phone Number: 6983075706
- Email: christinakolla@yahoo.gr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age over 18 years old
- Elective pancreaticoduodenectomy
- Signed consent form
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Antecolic gastrojejunostomy
|
Gastrojejunostomy in front of the transverse colon
|
|
Active Comparator: Retrocolic gastrojejunostomy
|
Gastrojejunostomy through the transverse mesocolon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delayed Gastric Emptying
Time Frame: 3 years
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Dimitrios Symeonidis, University of Thessaly
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- University hospital of Larissa
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
product manufactured in and exported from the U.S.
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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