Neoplasms

All Conditions

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients with non-lifting adenomas, adnomas at difficult anaotomic locations , T1-carcinomas or submucosal colorectal tumors

Endoscopic full thickness resection (EFTR)

Arthur R Schmidt, MD

Karel Caca, MD, PhD

Arthur Schmidt, MD

Karel Caca, Prof.

Arthur R Schmidt, Dr.

Observational prospective multicenter study to investigate efficacy and safety of endoscopic full thickness resection in the lower GI tract using a novel over-the-scope full thickness resection device.

The FTRD ("Full Thickness Resection Device", Ovesco Endoscopy, Tübingen, Germany) is an over the scope device consisting of a transparent cap with a preloaded monofilament snare and and a 14 mm modified Over-the-scope Clip. The device is CE marked for full thickness resection in the lower GI tract.

The study was designed to investigate efficacy and safety of this device for full thickness resection of colorectal lesions.

Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"

Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"- A Prospective Multicenter Trial

Successful enbloc- and macroscopically complete resection

Histologically confirmed complete resection

Histologically confirmed full thickness resection

Procedure-associated complications such as bleeding or perforation

Ovesco Endoscopy AG

Kliniken Ludwigsburg-Bietigheim gGmbH

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

FTRD (Ovesco company) in tumors up to 10 mm and predominantly intraluminal growth directly by sucking into the cap, at 10-20 mm and/or intramural/extramural growth by prior circumcision and lateral preparation, so that the lesions can be better pulled into the cap. The procedure depends on the endosonographic extent of the findings. The lesions are pulled into the cap with grippers and other instruments and, if necessary, with a snare and then resected with FTRD

removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)

Thomas Rösch, Prof. Dr.

Smaller submucosal tumors (SMT) in the stomach are usually seen as an incidental finding during a gastroscopy, although current diagnostics usually do not clearly indicate what type of tumor it is. In summary, there is no good evidence for dealing with SMT. In this study, an endoscopic full-thickness resection, primarily with the FTRD device, is to be offered to all patients with gastric SMT without a confirmed histology seen in a certain period of time . Patients who do not want to take advantage of this are included in a systematic follow-up program.

The investigators hope to learn about the rate of so-called GIST tumors and other histologies, as well as the rate of change in the follow-up group.

Also, study contents will be accuracy of endosonographic imaging and puncture in comparison with resection histology, technical feasibility and histological completeness of the FTRD- based endoscopic (full-wall) resection option, complications of such a resection (secondary bleeding and dehiscences), and patient preferences with standardized information.

Smaller submucous tumors in the stomach are usually seen as a random finding in gastroscopies and present a diagnostic dilemma to the doctor and patient:

type specification is usually unclear whether it is an absolutely benign (without degeneration potential) or a malignant or prone tumor (usually gastrointestinal stromal tumor, GIST). However, this is crucial for further management.

In endosonographic imaging there are only approximate values in the differential diagnosis between GIST and non-GIST, the endoscopic biopsy is too superficial, and the hit rate of endosonographic pin puncture is limited, and in most studies is less than 70% Therefore, one can only make assumptions and create a risk profile from imaging and tumor size (limit size 3 cm, partly also 2 cm). Both follow-up recommendations (rather no GIST) and laparoscopic surgical removal (proven or probable/possible GIST) are not rarely without clear preference, especially for smaller tumors.

For these indications, a simple endoscopic removal option comparable to the polypectomy in the colon (where no histological type diagnosis is made before) does not exist.

Previous studies are usually subject to bias in several directions:

1. The frequency of GIST tumors among submucous tumors/lesions (SMT) in the stomach is unclear. Gastroenterological series always contain smaller GIST tumors, but are reported almost exclusively from clinics. The rate of these tumors in the overall collective of patients seen in the field of (mostly established) gastroenterologists is thus completely unclear. Surgical or oncological series have usually included more aggressive tumors consisting mainly or exclusively of GIST tumors, therefore do not allow epidemiological conclusions.
2. If no surgery is performed (and thus a definitive histology is forced), only information from follow-up examinations remains. Previous follow-up studies show the dilemma of insufficient differential diagnosis of lesions by endosonography and (endosonographic or other) biopsy, which usually have insufficient accuracy. In addition, the follow-up time in the studies hardly extends beyond 2 years. The "gastroenterological gut instinct" that these small lesions are not dangerous may be true, but is not proven.

Submucosal gastric Tumors up to 2 centimeters of size

Submucosal Tumor Removal by Endoscopic Excision Therapy

Prospective One-armed Observational Study of Full-thickness Resection of Small Hypoechoic Submucosal Gastric Tumors (≤2 cm)

Rate of GIST tumors in a preferably unselected patient cohort of small submucous gastric tumors in which histology is not known

Technical success rate (R0/R1 resection) of the chosen resection technique

Complication rate of the chosen resection technique

Influence of tumor position in the stomach

endoscopic ultrasound image with pattern and position in the wall

Patient preferences for removal (consent rate for the study) versus follow-up

Establishment of a date base for a cost-benefit calculation comparing follow-up vs. removal

Universitätsklinikum Hamburg-Eppendorf

Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD).

Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy).

dFTRD

Markus Bauder, MD

Karel Caca, Prof. Dr. med.

Sandra Wennemuth

Prospective, randomized multi-center trial. Comparison of Endoscopic Mucosal Resection (EMR) versus Endoscopic Full-Thickness Resection with the duodenal Full-Thickness Resection Device (dFTRD) of non-ampullary duodenal adenomas.

Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)

Composite endpoint of perforations and relevant bleeding

time span of the procedure according to sedation protocol

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"	NCT02362126	Colorectal Aden... Submucosal Tumo...	Endoscopic full...	18 Years -	Kliniken Ludwigsburg-Bietigheim gGmbH
Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"	NCT02362126	Colorectal Aden... Submucosal Tumo...	Endoscopic full...	18 Years -	Kliniken Ludwigsburg-Bietigheim gGmbH
Submucosal Tumor Removal by Endoscopic Excision Therapy	NCT04913077	Submucosal Tumo...	removal of subm...	18 Years - 80 Years	Universitätsklinikum Hamburg-Eppendorf
Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)	NCT03559231	Duodenal Adenom...	dFTRD EMR	18 Years -	Kliniken Ludwigsburg-Bietigheim gGmbH

Spots Global Cancer Trial Database for ftrd

Every month we try and update this database with for ftrd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ftrd

Every month we try and update this database with for ftrd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ftrd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.