Clinical trial NCT04423588: Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bariatric Surgery
Keywords: Proton Pump Inhibitor
Lead sponsor: Spital Limmattal Schlieren
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of dexlansoprazole Serum concentration
timeFrame: 3 months
measure: Change of dexlansoprazole Serum concentration
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Marginal ulceration
timeFrame: 6 months
measure: Incidence of Marginal ulceration
timeFrame: 12 months
measure: Incidence of Marginal ulceration
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Chefarzt Chirurgie, Limmattal Hospital
name: Urs Zingg, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: