Safety and Efficacy Study of the FTRD System for Obtaining Full-thickness Intestinal Biopsies

Not Applicable

Withdrawn

• Conditions: Gastrointestinal Motility Disorders
• Interventions: Procedure: Endoscopic full-thickness biopsy

• Registration Number: NCT02673983
• Lead Sponsor: Region Skane

Brief Summary

The aim of this study is to evaluate FTRD (full-thickness resection device) in terms of obtaining full-thickness biopsies form the gastrointestinal tract endoscopically in the work-up of patients with gastrointestinal motility disorders.

Detailed Description

Functional intestinal disorders are a common problem and diagnosis is a challenge to clinicians. Several motility disorders are caused by pathological changes in the neuromuscular network in the intestinal wall. To obtain a diagnosis a full-thickness biopsy is required. At present, this kind of biopsy is usually obtained by a laparoscopic surgical procedure, requiring full anesthesia, operating room and several days of postoperative care in the hospital. Today, there is lacking a more minimal invasive approach for obtaining full-thickness biopsies from the gastrointestinal tract. A new device has been developed called full-thickness resection device (FTRD), which has proved useful and safe from removing polyps in the gastrointestinal tract (Schmidt A Endoscopy 47;8, 719-725). The specific aims of this study is to determine if FTRD safe for obtaining full-thickness biopsies form the gastrointestinal tract and whether these FTRD biopsies be used for clinical diagnosis of patients with suspected intestinal motility disorders. If these aims can be achieved FTRD would be of potential great value for patients and health care in the management of patients with gastrointestinal disorders. 40 patients will be included, i.e. 10 patients will undergo FTRD biopsy in the sigmoid colon, distal ileum, jejunum and duodenum. Patients will undergo the biopsy procedure under conscious sedation at the Endoscopy Unit in Malmö, Region Skane and stay one night at the hospital to detect any complications. A venous blood sample will be taken before and 24 hours after the biopsy for examination of systemic inflammatory changes. All biopsies will examined by an expert in neuromuscular pathology.

Study Timeline

• Study First Submitted: 2016-01-15
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with functional gastrointestinal motility disorders in which a full-thickness biopsy is needed to obtain a clinical diagnosis.

Exclusion Criteria

• Patients less than 18 years old and patients not giving consent to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing endoscopic full-thickness biopsy	Endoscopic full-thickness biopsy	-

Primary Outcome Measures

Name	Time	Method
Safety: The number of patients with bleeding or perforation will be determined and reported.	24 hours	Upon signs of clinical significant bleeding a colonoscopy will be performed and upon clinical signs of perforation will the patient undergo a computer tomography. The number of patients with bleeding or perforation will be determined and reported.

Secondary Outcome Measures

Name	Time	Method
Efficacy: The number of patients in which a clinical diagnosis was obtained based on the full thickness biopsy will be determined and reported.	4-8 weeks when pathological examination is completed	The number of patients in which a clinical diagnosis was obtained based on the full thickness biopsy will be determined and reported.