Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer

Not Applicable

Withdrawn

• Conditions: Stomach Neoplasms
• Interventions: Device: Boston Scientific Large Capacity with needle Biopsy; Device: Endodrill 1A (BIBBInstruments, Lund, Sweden)

• Registration Number: NCT02594943
• Lead Sponsor: Region Skane

Brief Summary

Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows:

* Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis of diffuse gastric cancer based on collected biopsies from tumor tissue.

Detailed Description

Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators´ first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps.

In this study, the investigators want to compare the Endodrill instrument´s ability to obtain representative tissue samples from a group of patients diagnosed with or suspected diffuse gastric cancer. 20 patients will be enrolled for this study. For each patient the investigators will collect 8 biopsies, 4 biopsies each with conventional biopsy and the Endodrill instrument respectively. The order will be randomized for each patient. For each specific biopsy the investigator will choose a particular site on the suspected tumor tissue without knowing which instrument that will be used for the biopsy. This procedure will be repeated for all 8 biopsies.

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-03
• Study Start: 2018-08
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-22
• Last Update Posted: 2018-11-26
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

• Patients with suspected or with an established diagnosis of diffuse gastric cancer who are capable of stating a formal consent to participate in the study.

Exclusion Criteria

• Mental illness
• Extreme co-morbidity (ASA>3)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Biopsy	Boston Scientific Large Capacity with needle Biopsy	4 out of 8 biopsies taken with a Boston Scientific Large capacity with needle biopsy forceps from the suspected tumor tissue in the stomach. They will be taken in random order "blinded" for the person performing the examination.
Endodrill Biopsy	Endodrill 1A (BIBBInstruments, Lund, Sweden)	4 out of 8 biopsies taken with the Endodrill 1A instrument from the suspected tumor tissue in the stomach. They will be taken in random order "blinded" for the person performing the examination.

Primary Outcome Measures

Name	Time	Method
Highest proportion (number) of representative biopsies from tumors of diffuse gastric cancer	24 months

Secondary Outcome Measures

Name	Time	Method
Amount of (mm2 and %) submucosal tissue within the biopsies.	24 months