Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass

NCT04423588 | Withdrawn Phase 4

• 1 other identifier: 2019-02326
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bariatric Surgery

Keywords

Proton Pump Inhibitor

Outcome Measures

Primary Outcomes (2)

• 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

  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

  6 months

Secondary Outcomes (3)

• Incidence of Marginal ulceration

  6 months

• Incidence of Marginal ulceration

  12 months

• Incidence of Marginal ulceration

  6 months

Study Arms (1)

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.

Diagnostic Test: dexlansoprazole serum concentration; Diagnostic Test: upper endoscopy

Interventions

dexlansoprazole serum concentration DIAGNOSTIC_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.

Dexlansoprazole

upper endoscopy DIAGNOSTIC_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.

Dexlansoprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spital Limmattal Schlieren: lead

MeSH Terms

Interventions

Gastroscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Urs Zingg, Prof. Dr. med.

  Chefarzt Chirurgie, Limmattal Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Urs Zingg

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: June 9, 2020
• Study Start: January 1, 2022
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: December 2, 2024

Record last verified: 2024-11