Gastric BypassNCT05357443
SH Dr. Chen Gastric Bypass Study
A study testing Gastric bypass with transection of vagal nerves and Gastric bypass without transection of vagal nerves in people with Gastric Bypass, run by Sanford Health at 1 site in United States.
Trial summary
Evaluation of serum gastrin levels and their effect on marginal ulcer formation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Bypass
- What is being tested?
- Gastric bypass with transection of vagal nerves and Gastric bypass without transection of vagal nerves
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2022to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
- Capable of giving signed informed consent.
Who cannot join
- Under 18 years of age
- Ineligible for gastric bypass surgery
- Pregnant women or women actively seeking to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation
Evaluation of serum gastrin levels and their effect on marginal ulcer formation.
Read the 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.
- Conditions
- Gastric Bypass
- Being tested
- Gastric bypass with transection of vagal nerves, Gastric bypass without transection of vagal nerves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypass with transection of vagal nervesProcedure or surgery
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 nervesProcedure or surgery
Dissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass with Transection of Vagal Nerves | Active comparator | Not described Receives: Procedure: Gastric bypass with transection of vagal nerves |
| Gastric Bypass Without Transection of Vagal Nerves | Placebo comparator | Not described Receives: Procedure: Gastric bypass without transection of vagal nerves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Marginal Ulcer
Number of participants with a change in serum gastrin levels compared pre- and post-surgery.
Measured: From surgical intervention to five years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start31 Aug 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sugong Chen, MD, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357443
- Sponsor's protocol ID
- SH Gastric Bypass Study
- Status last verified
- Sep 2025
- First submitted
- 19 Apr 2022
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation
- ClinicalTrials.gov ID
- NCT05357443
- Acronym / sponsor ID
- SH Gastric Bypass Study
- Conditions
- Gastric Bypass
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass with Transection of Vagal Nerves | Active comparator | Procedure: Gastric bypass with transection of vagal nerves |
| Gastric Bypass Without Transection of Vagal Nerves | Placebo comparator | Procedure: Gastric bypass without transection of vagal nerves |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and older
- Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
- Capable of giving signed informed consent.
Key exclusion criteria (3 listed)
- Under 18 years of age
- Ineligible for gastric bypass surgery
- Pregnant women or women actively seeking to become pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric bypass with transection of vagal nervesVagal 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 or surgery | Gastric Bypass with Transection of Vagal Nerves |
| Gastric bypass without transection of vagal nervesDissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique. | Procedure or surgery | Gastric Bypass Without Transection of Vagal Nerves |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sugong Chen, MD principal investigator
Sanford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric bypass with transection of vagal nerves and Gastric bypass without transection of vagal nerves in people with Gastric Bypass, run by Sanford Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Marginal Ulcer (time frame: From surgical intervention to five years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.