Clinical trial NCT02673983: Safety and Efficacy Study of the FTRD System for Obtaining Full-thickness Intestinal Biopsies
Official title: Endoscopic Full-thickness Biopsy of the Intestine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastrointestinal Motility Disorders
Keywords: Intestinal
Biopsy
full thickness
endoscopic
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2016-02-04
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: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety: The number of patients with bleeding or perforation will be determined and reported.
timeFrame: 24 hours
Secondary outcomes:
measure: Efficacy: The number of patients in which a clinical diagnosis was obtained based on the full thickness biopsy will be determined and reported.
timeFrame: 4-8 weeks when pathological examination is completed
Other outcomes:
Locations:
Study officials:
affiliation: Region Skane, Department of Surgery
name: Henrik Thorlacius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt A, Bauerfeind P, Gubler C, Damm M, Bauder M, Caca K. Endoscopic full-thickness resection in the colorectum with a novel over-the-scope device: first experience. Endoscopy. 2015 Aug;47(8):719-25. doi: 10.1055/s-0034-1391781. Epub 2015 Mar 12.