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NCT Number: NCT05357443

SH Dr. Chen Gastric Bypass Study

Evaluation of serum gastrin levels and their effect on marginal ulcer formation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastric Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanford Health

Fargo, North Dakota, 58102, United States

About this study

Prospective, randomized, interventional trial. Participants will be randomized to one of two surgical techniques, either with transection of the vagal nerves, or without. Outcomes including compare marginal ulcer rates will be compared using serum gastrin levels before and after surgery and gastric pH during surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years and older
  • Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
  • Capable of giving signed informed consent.

Exclusion criteria

  • Under 18 years of age
  • Ineligible for gastric bypass surgery
  • Pregnant women or women actively seeking to become pregnant.

Treatment and study plan

Gastric bypass with transection of vagal nerves

Procedure

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.

Gastric bypass without transection of vagal nerves

Procedure

Dissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique.

Primary outcomes

  1. Incidence of Marginal Ulcer

    Time frame: From surgical intervention to five years after surgery

    Number of participants with a change in serum gastrin levels compared pre- and post-surgery.

Sponsors and collaborators

Lead sponsor

Sanford Health

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
May 2, 2022
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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