Study Stopped
Interim analysis showed very low possibility for significant differences between the two instruments.
Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis
1 other identifier
interventional
7
1 country
1
Brief Summary
Endodrill is a new instrument for biopsy sampling in the GI-channel. The purposes of this study are as follows:
- Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis based on collected biopsies of tumors in the upper GI tract.
- Based on the quality of the collected tissue samples we want to evaluate which instrument generates the most useful material for genetic studies of the tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2015
CompletedFirst Posted
Study publicly available on registry
November 10, 2015
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedMarch 17, 2020
March 1, 2020
2.7 years
October 27, 2015
March 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Highest proportion (number) of representative biopsies for diagnostic purposes from the tumor tissue.
12 months
Secondary Outcomes (2)
Number of genetic point mutations in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.
12 months
Number of fusion genes in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.
12 months
Study Arms (2)
Conventional biopsy
ACTIVE COMPARATOR4 out of 8 biopsies taken with a conventional biopsy forceps from the tumor tissue in the distal esophagus and cardia. The biopsies will be taken in random order "blinded" for the person performing the examination. 1 additional biopsy will be taken from the tumor tissue in order to be evaluated for appropriateness of further genetic analysis. Both type of biopsies will be taken from the same patient. In total 10 biopsies per patient.
Endodrill biopsy
ACTIVE COMPARATOR4 out of 8 biopsies taken with the Endodrill instrument from the tumor tissue in the distal esophagus and cardia. The biopsies will be taken in random order "blinded" for the person performing the examination. 1 additional biopsy will be taken from the tumor tissue in order to be evaluated for appropriateness of further genetic analysis. Both type of biopsies will be taken from the same patient. In total 10 biopsies per patient.
Interventions
Testing a new device for taking tissue biopsies in the GI tract. The investigators will use the Endodrill instrument in order to sample high quality biopsies from tumor tissue in the distal esophagus and cardia. The investigators will also investigate to what extent the Endodrill instrument can generate biopsies with the correct diagnosis and also evaluate the possibility for genetic studies of the harvested tumor tissue.
Using a conventional biopsy forceps for taking tissue biopsies in the GI tract. The investigators will use conventional biopsy forceps in order to sample high quality biopsies from tumor tissue in the distal esophagus and cardia. The investigators will also investigate to what extent the conventional biopsy forceps can generate biopsies with the correct diagnosis and also evaluate the possibility for genetic studies of the harvested tumor tissue.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with adenocarcinoma of the distal esophagus/cardia or stomach capable of stating a formal consent to participate in the study.
You may not qualify if:
- Mental illness
- Extreme co-morbidity (ASA \>3)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
University Hospital of Lund
Lund, Skåne County, 22185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Johansson, SrConsultant
Region Skåne
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 10, 2015
Study Start
September 1, 2016
Primary Completion
May 30, 2019
Study Completion
June 1, 2019
Last Updated
March 17, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share