Neoplasms

Digestive System Diseases

All Conditions

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

Ovesco Endoscopy AG

Universitätsklinikum Hamburg-Eppendorf

simple non-exposure EFTR group (single arm study)

This intervention includes the steps of laparoscopic seromuscular suturing with a barbed suture thread (V-Loc), which results in inversion of the stomach wall; EFTR of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips.

simple non-exposure EFTR

Chan G Kim, M.D.

This study evaluates the feasibility of endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) in patients with gastric tumor.

Current endoscopic full-thickness resection (EFTR) methods are limited by their transmural communication and exposure of tumor to peritoneum. Recently, endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) was developed. This new technique includes the steps of laparoscopic seromuscular suturing with a barbed suture thread (V-Loc), which results in inversion of the stomach wall; EFTR of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips.

This study evaluates the feasibility of simple non-exposure EFTR technique in patients with gastric tumor. This study is single arm study and will be performed in single center.

Endoscopic Full Thickness Resection Without Exposure to Peritoneum

Endoscopic Full Thickness Resection Without Exposure to Peritoneum: Single Center Single Arm Study

National Cancer Center, Korea

Senior Scientist

Skin and Connective Tissue Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

patients with suspected gastric GIST with size \> 2cm are subjected for laparoscopic resection.

all patients with suspected Gastric GIST undergoes laparoscopic resection. Tumour location decides the approach used for resection. Therefore, a variety of options such as local resections, wedge resections, transgastric resections, intragastric resection and partial gastrectomies were performed.

Laparoscopic resection

sandeep sabnis, DNB SGE

Gastric GISTs are rare neoplasms that require excision for cure. Although the feasibility of laparoscopic resection of gastric GIST less than 2cms has been established, the feasibility, safety and long-term efficacy of these techniques for larger lesions are unclear. Investigators hypothesized that laparoscopic resection of gastric GISTs even for larger lesions is feasible \& results in low perioperative morbidity and an effective long-term control of the disease.

Open surgical resection was the standard of treatment until two decades ago, but with advent laparoscopy and experienced gained over the years, the safety \& feasibility of laparoscopic resections of gastric GISTs has been proven but for tumors less than 2 cm. However, with gain of experience and skill in laparoscopic surgery, many surgeons have reported a safety \& feasibility excision of tumors greater than 5 cm. Our current study demonstrates the oncologic safety of the laparoscopic approach even with tumour size range up to 12cm, with efficacy and recurrence rates similar or superior to historical open surgical controls, however, it requires considerable expertise for safe manipulation of the tumour. All these resections were accomplished with minimal morbidity, no perioperative mortality, and short post-operative stay and comparable long term oncological outcomes.

Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach

Gastrointestinal Stromal Tumor of Stomach: Feasibility of Laparoscopic Resection in Large Lesions and Its Long Term Outcomes- A Case Series

Any instances of tumour rupture during surgery is noted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Submucosal Tumor Removal by Endoscopic Excision Therapy	NCT04913077	Submucosal Tumo...	removal of subm...	18 Years - 80 Years	Universitätsklinikum Hamburg-Eppendorf
Endoscopic Full Thickness Resection Without Exposure to Peritoneum	NCT02764944	Submucosal Tumo...	simple non-expo...	20 Years -	National Cancer Center, Korea
Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach	NCT03722056	Gastric GIST Submucosal Tumo...	Laparoscopic re...	18 Years -	GEM Hospital & Research Center
Endoscopic Full Thickness Resection Without Exposure to Peritoneum	NCT02764944	Submucosal Tumo...	simple non-expo...	20 Years -	National Cancer Center, Korea

Spots Global Cancer Trial Database for submucosal tumor of stomach