Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass

Bariatric Surgery Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04423588
• Other study ID #: 2019-02326
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2022
• Source: Spital Limmattal Schlieren
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spital Limmattal Schlieren

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Incidence of Marginal ulceration	Study of the incidence of marginal ulcers in the participants 6 months after surgery	6 months
Secondary	Incidence of Marginal ulceration	Study of the incidence of marginal ulcers in the participants 12 months after surgery	12 months
Secondary	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