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

NCT02594943 | Withdrawn

• 1 other identifier: Endodrill II
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stomach Neoplasms

Keywords

Diagnostics; Biopsy; Diffuse gastric cancer

Outcome Measures

Primary Outcomes (1)

• Highest proportion (number) of representative biopsies from tumors of diffuse gastric cancer

  24 months

Secondary Outcomes (1)

• Amount of (mm2 and %) submucosal tissue within the biopsies.

  24 months

Study Arms (2)

Conventional Biopsy

ACTIVE COMPARATOR

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.

Device: Boston Scientific Large Capacity with needle Biopsy

Endodrill Biopsy

ACTIVE COMPARATOR

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.

Device: Endodrill 1A (BIBBInstruments, Lund, Sweden)

Interventions

Boston Scientific Large Capacity with needle Biopsy DEVICE

The investigators will use a conventional biopsy forceps for taking tissue biopsies in the GI tract. In a randomized order 4 out of total 8 biopsies will be taken with the conventional biopsy forceps from the tumor tissue.

Conventional Biopsy

Endodrill 1A (BIBBInstruments, Lund, Sweden) DEVICE

The investigators will use the Endodrill, a new device for endoscopic tissue sampling in the GI tract. In a randomized order 4 out of total 8 biopsies will be taken with the Endodrill instrument from the tumor tissue.

Endodrill Biopsy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

MeSH Terms

Conditions

Stomach Neoplasms; Carcinoma, Signet Ring Cell

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Jan Johansson, SrConsultant

  Region Skåne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Surgeon

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: November 3, 2015
• Study Start: August 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 26, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share