SH Dr. Chen Gastric Bypass Study
Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation
1 other identifier
interventional
50
1 country
1
Brief Summary
Evaluation of serum gastrin levels and their effect on marginal ulcer formation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
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
April 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 2, 2022
CompletedStudy Start
First participant enrolled
August 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
September 30, 2025
September 1, 2025
4 years
April 19, 2022
September 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Marginal Ulcer
Number of participants with a change in serum gastrin levels compared pre- and post-surgery.
From surgical intervention to five years after surgery
Study Arms (2)
Gastric Bypass with Transection of Vagal Nerves
ACTIVE COMPARATORGastric Bypass Without Transection of Vagal Nerves
PLACEBO COMPARATORInterventions
Vagal nerve interruption above the level of the stomach is a known treatment for complicated peptic ulcer disease. It is not commonly performed during routine gastric bypass. The vagi are, however, interrupted part-way down the stomach to create the gastric pouch. This is the pars flaccida technique.
Dissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique.
Eligibility Criteria
You may qualify if:
- Age 18 years and older
- Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
- Capable of giving signed informed consent.
You may not qualify if:
- Under 18 years of age
- Ineligible for gastric bypass surgery
- Pregnant women or women actively seeking to become pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanford Healthlead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Sanford Health
Fargo, North Dakota, 58102, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sugong Chen, MD
Sanford Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2022
First Posted
May 2, 2022
Study Start
August 31, 2022
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share