Bariatric SurgeryPhase 4NCT04423588
Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass
A Phase 4 study testing dexlansoprazole serum concentration and upper endoscopy in people with Bariatric Surgery, run by Spital Limmattal Schlieren.
Trial summary
In Switzerland, the most commonly performed bariatric procedure is the proximal Roux-en-y gastric Bypass surgery. Since marginal ulceration is a known complication after this Operation, a Proton pump Inhibitor (PPI) prophylaxis is prescribed postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- dexlansoprazole serum concentration and upper endoscopy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent for study and surgery as documented by signature
- Male and Female Patients over 18 years old eligible for bariatric surgery at the Department of General Surgery, Limmattal Hospital, according to criteria of the Swiss Study Group for Morbid Obesity (SMOB) and international Guidelines
- BMI ≥ 35
- Failure of conservative Treatment for 2 years
- Type of surgery: LPRYGB
- Helicobacter pylori negative
- Smoker (≥ 1 cigarette daily)
- Women in reproductive Age: negative pregnancy test
Who cannot join
- Contraindication for a bariatric surgery according to SMOB-criteria
- Contraindication for PPIs
- Pregnant or breastfeeding women
- Pre- or intraoperative decision for other type of surgery than LPRYGB
- Active malignancy
- Chronic liver disease Child-Pugh B or C
- Abuse of drugs or alcohol
- Suspect of non-compliance
About this study
Official title: Prospective, Monocentric Study of Dexlansoprazole Absorption Preoperative and 6 and 12 Months After Proximal Roux-en-Y Gastric Bypass Surgery and of the Incidence of Marginal Ulcers 6 and 12 Months After Surgery
In Switzerland, the most commonly performed bariatric procedure is the proximal Roux-en-y gastric Bypass surgery. Since marginal ulceration is a known complication after this Operation, a Proton pump Inhibitor (PPI) prophylaxis is prescribed postoperatively. Bariatric surgery may have an impact on the absorption and consequently on the efficacy of drugs. There are only very little data on the pharmacokinetics of PPIs following PRYGB.
The aim of this study is to analyze the serum concentration of dexlansoprazole preoperative and after PRYGB surgery in patients taking PPI prophylaxis and to examine the incidence of marginal ulcers postoperatively in the same population.
Read the detailed description
This prospective, monocentric study includes 30 patients undergoing a proximal Roux-en-Y gastric Bypass surgery and receiving 6 months of postoperative PPI prophylaxis with Dexilant (dexlansoprazole). The aim is to examine if the LPRYGB has an impact on the absorption of dexlansoprazole. Peripheral blood samples from the study participants are obtained at fixed time points after oral Administration of a capsule Dexilant preoperatively as well as 3 and 6 months after surgery. The incidence of marginal ulceration in the same patient population is assessed by upper endoscopy 6 and 12 months after surgery. The surgery, the PPI prophylaxis and the upper endoscopy 12 months post-surgery aren't for study purpose. Data collection is made by measuring serum drug concentration, patient questionnaires, pill count and upper endoscopy.
- Conditions
- Bariatric Surgery
- Being tested
- dexlansoprazole serum concentration, upper endoscopy
- Keywords
- Proton Pump Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexlansoprazole serum concentrationDiagnostic test
6 blood samples are collected at fixed time Points after oral Administration of 1 dose of dexilant at regular patients visits preoperatively and 3 and 6 months post-surgery.
upper endoscopyDiagnostic test
6 and 12 months after surgery the occurrence of marginal ulcers in the same Patient Group is examined by upper endoscopy. The 12-month endoscopy is part of the Routine postoperative diagnosis, the 6-month endoscopy is for study purpose.
| Study group | Role | What they receive |
|---|---|---|
| Dexlansoprazole | Other | The PPI Dexilant (active substance: dexlansoprazole) is administered to the study participants in a prophylactic Regimen for 6 months after the PRYGB-surgery. This drug is already approved by Swissmedic and on the markets in Switzerland. The dosage is 1 capsule 60 mg per os daily in the morning. Receives: Diagnostic Test: dexlansoprazole serum concentration; Diagnostic Test: upper endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of dexlansoprazole Serum concentration
Determination of the dexlansoprazole concentration (ng/ml) in the participants blood at time 0, 60, 90, 120, 210, 300 min after having swallowed a Dosis of dexilant preoperatively and 3 months after surgery
Measured: 3 months
Change of dexlansoprazole Serum concentration
Determination of the dexlansoprazole concentration (ng/ml) in the participants blood at time 0, 60, 90, 120, 210, 300 min after having swallowed a Dosis of dexilant preoperatively and 6 months after surgery
Measured: 6 months
Secondary outcomes (3)
Incidence of Marginal ulceration
Study of the incidence of marginal ulcers in the participants 6 months after surgery
Measured: 6 months
Incidence of Marginal ulceration
Study of the incidence of marginal ulcers in the participants 12 months after surgery
Measured: 12 months
Incidence of Marginal ulceration
Study of the incidence of marginal ulcers in participants undergoing a upper endoscopy in the presence of symptoms Prior to the end of the 6 post-operative months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jan 2022
- Primary completion31 Mar 2022
- Study completion30 Sep 2022
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spital Limmattal Schlieren
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Urs Zingg, Spital Limmattal Schlieren
- Investigators
- Urs Zingg, Prof. Dr. med., Principal investigator, Chefarzt Chirurgie, Limmattal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423588
- Sponsor's protocol ID
- 2019-02326
- Other IDs
- 2019
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2020
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Monocentric Study of Dexlansoprazole Absorption Preoperative and 6 and 12 Months After Proximal Roux-en-Y Gastric Bypass Surgery and of the Incidence of Marginal Ulcers 6 and 12 Months After Surgery
- ClinicalTrials.gov ID
- NCT04423588
- Acronym / sponsor ID
- 2019-02326
- Conditions
- Bariatric Surgery
- Keywords
- Proton Pump Inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Spital Limmattal SchlierenUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Jun 2020 (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.
In Switzerland, the most commonly performed bariatric procedure is the proximal Roux-en-y gastric Bypass surgery. Since marginal ulceration is a known complication after this Operation, a Proton pump Inhibitor (PPI) prophylaxis is prescribed postoperatively. Bariatric surgery may have an impact on the absorption and consequently on the efficacy of drugs. There are only very little data on the pharmacokinetics of PPIs following PRYGB.
The aim of this study is to analyze the serum concentration of dexlansoprazole preoperative and after PRYGB surgery in patients taking PPI prophylaxis and to examine the incidence of marginal ulcers postoperatively in the same population.
Detailed description
This prospective, monocentric study includes 30 patients undergoing a proximal Roux-en-Y gastric Bypass surgery and receiving 6 months of postoperative PPI prophylaxis with Dexilant (dexlansoprazole). The aim is to examine if the LPRYGB has an impact on the absorption of dexlansoprazole. Peripheral blood samples from the study participants are obtained at fixed time points after oral Administration of a capsule Dexilant preoperatively as well as 3 and 6 months after surgery. The incidence of marginal ulceration in the same patient population is assessed by upper endoscopy 6 and 12 months after surgery. The surgery, the PPI prophylaxis and the upper endoscopy 12 months post-surgery aren't for study purpose. Data collection is made by measuring serum drug concentration, patient questionnaires, pill count and upper endoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexlansoprazole | Other | Diagnostic Test: dexlansoprazole serum concentration, Diagnostic Test: upper endoscopyThe PPI Dexilant (active substance: dexlansoprazole) is administered to the study participants in a prophylactic Regimen for 6 months after the PRYGB-surgery. This drug is already approved by Swissmedic and on the markets in Switzerland. The dosage is 1 capsule 60 mg per os daily in the morning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent for study and surgery as documented by signature
- Male and Female Patients over 18 years old eligible for bariatric surgery at the Department of General Surgery, Limmattal Hospital, according to criteria of the Swiss Study Group for Morbid Obesity (SMOB) and international Guidelines
- BMI ≥ 35
- Failure of conservative Treatment for 2 years
- Type of surgery: LPRYGB
Key exclusion criteria (8 listed)
- Contraindication for a bariatric surgery according to SMOB-criteria
- Contraindication for PPIs
- Pregnant or breastfeeding women
- Pre- or intraoperative decision for other type of surgery than LPRYGB
- Active malignancy
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 |
|---|---|---|
| dexlansoprazole serum concentration6 blood samples are collected at fixed time Points after oral Administration of 1 dose of dexilant at regular patients visits preoperatively and 3 and 6 months post-surgery. | Diagnostic test | Dexlansoprazole |
| upper endoscopy6 and 12 months after surgery the occurrence of marginal ulcers in the same Patient Group is examined by upper endoscopy. The 12-month endoscopy is part of the Routine postoperative diagnosis, the 6-month endoscopy is for study purpose. | Diagnostic test | Dexlansoprazole |
Primary outcome
Change of dexlansoprazole Serum concentration
Time frame: 3 months
Determination of the dexlansoprazole concentration (ng/ml) in the participants blood at time 0, 60, 90, 120, 210, 300 min after having swallowed a Dosis of dexilant preoperatively and 3 months after surgery
Change of dexlansoprazole Serum concentration
Time frame: 6 months
Determination of the dexlansoprazole concentration (ng/ml) in the participants blood at time 0, 60, 90, 120, 210, 300 min after having swallowed a Dosis of dexilant preoperatively and 6 months after surgery
3 secondary outcomes
Incidence of Marginal ulceration
Time frame: 6 months
Incidence of Marginal ulceration
Time frame: 12 months
Incidence of Marginal ulceration
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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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.
Urs Zingg, Prof. Dr. med. principal investigator
Chefarzt Chirurgie, Limmattal Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexlansoprazole serum concentration and upper endoscopy in people with Bariatric Surgery, run by Spital Limmattal Schlieren.
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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change of dexlansoprazole Serum concentration (time frame: 3 months). The study lists 2 primary outcomes in all. 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 9 Jun 2026.