Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass

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.

Study Overview

• Status: Withdrawn
• Conditions: Bariatric Surgery
• Intervention / Treatment: Diagnostic test: dexlansoprazole serum concentration; Diagnostic test: upper endoscopy

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 Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Dexlansoprazole; 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; 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.; Diagnostic test: upper endoscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Marginal ulceration	Study of the incidence of marginal ulcers in the participants 6 months after surgery	6 months
Incidence of Marginal ulceration	Study of the incidence of marginal ulcers in the participants 12 months after surgery	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	6 months

Collaborators and Investigators

• Sponsor: Spital Limmattal Schlieren
• Investigators: Principal Investigator: Urs Zingg, Prof. Dr. med., Chefarzt Chirurgie, Limmattal Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Proton Pump Inhibitor
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: 2019-02326

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No