Clinical trial NCT02601079: Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis
Official title: Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis in Tumors of the Distal Esophagus and Cardia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Neoplasm
Keywords: Biopsy
Diagnostics
Genetic analysis
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 tumors in the distal esophagus and cardia with a conventional biopsy forceps. In addition the investigators want to compare the tissue samples in terms of weight, quality, artefacts and whether either instrument is more suited for collecting tissue for genetic analysis. Such analysis will be conducted with Next-Generation Sequensing (NGS) of the whole exome, Whole Exome Sequensing (WES). In the event of positive results from these analysis the investigators will also conduct RNA-sequencing of the tumor tissue in order to start pre-operative mapping of genetic abnormalities.

20 patients will be enrolled for this study. For each patient the investigators will collect 10 biopsies, 5 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 10 biopsies.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with adenocarcinoma of the distal esophagus/cardia or stomach capable of stating a formal consent to participate in the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Highest proportion (number) of representative biopsies for diagnostic purposes from the tumor tissue.
timeFrame: 12 months
Secondary outcomes:
measure: Number of genetic point mutations in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.
timeFrame: 12 months
measure: Number of fusion genes in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.
timeFrame: 12 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: University Hospital of Lund
state: Skane
Study officials:
affiliation: Region Skåne
name: Jan Johansson, SrConsultant
role: PRINCIPAL_INVESTIGATOR
References: