SH Dr. Chen Gastric Bypass Study

• ClinicalTrials.gov Identifier: NCT05357443
• Recruitment Status: Active, not recruiting
• First Posted: May 2, 2022
• Last Update Posted: February 9, 2024
• Sponsor: Sanford Health
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Sanford Health

Tracking Information

• First Submitted Date: April 19, 2022
• First Posted Date: May 2, 2022
• Last Update Posted Date: February 9, 2024
• Actual Study Start Date: August 31, 2022
• Estimated Primary Completion Date: February 28, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2022)

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.

Original Primary Outcome Measures (submitted: April 27, 2022)

Incidence of Marginal Ulcer [ Time Frame: From surgical intervention to five years after surgery ]

Number of participants who develop marginal ulcer after gastric bypass utilizing transection of the vagal nerves technique versus without transection of the vagal nerves.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SH Dr. Chen Gastric Bypass Study
• Official Title: Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation
• Brief Summary: Evaluation of serum gastrin levels and their effect on marginal ulcer formation.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Bypass

Intervention

• Procedure: Gastric bypass with transection of vagal nerves
  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.
• Procedure: Gastric bypass without transection of vagal nerves
  Dissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique.

Study Arms

• Active Comparator: Gastric Bypass with Transection of Vagal Nerves
  Intervention: Procedure: Gastric bypass with transection of vagal nerves
• Placebo Comparator: Gastric Bypass Without Transection of Vagal Nerves
  Intervention: Procedure: Gastric bypass without transection of vagal nerves

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 27, 2022): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 28, 2026
• Estimated Primary Completion Date: February 28, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05357443
• Other Study ID Numbers: SH Gastric Bypass Study
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sanford Health
• Original Responsible Party: Same as current
• Current Study Sponsor: Sanford Health
• Original Study Sponsor: Same as current
• Collaborators: National Institutes of Health (NIH)

Investigators

• Principal Investigator: Sugong Chen, MD; Sanford Health

• PRS Account: Sanford Health
• Verification Date: February 2024