Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor

November 29, 2021 updated by: Shanghai Zhongshan Hospital

Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Endoscopic Resection And Laparoscopic Partial Gastrectomy In Patients With 2-5cm Gastric Gastrointestinal Stromal Tumor

This research is a prospective, multi-center trial for endoscopic resection and laparoscopic partial gastrectomy in patients with 2-5cm gastric gastrointestinal stromal tumor. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of endoscopic resection compared with laparoscopic partial gastrectomy for 2-5cm gastric gastrointestinal stromal tumor. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastrointestinal stromal tumors (GIST) originate from interstitial cells of Cajal (ICC) and are the most common tumors derived from mesenchymal tissues of the digestive tract. GISTs can occur in any part of the digestive tract, among which gastric stromal tumors are the most common, accounting for about 60%. The incidence of GIST has been increasing in recent years, partly due to the gradual popularity of gastrointestinal endoscopy. Many early GISTs with smaller tumors have also received early diagnosis and treatment intervention. Due to the potential malignancy of GISTs, complete resection of the tumor is the first and only radical treatment option currently.

Many studies have shown that laparoscopy is safe and effective approach in the treatment of gastric stromal tumors. In principle, as long as the tumor can be completely resected (neither residue macro nor microscopic) with intact tumor capsule and without tumor rupture, laparoscopic surgery is definite an option. Studies showed both short-term and long-term results of laparoscopic surgery were comparable to conventional open surgeries.

On the other hand, endoscopic resection showed promising results in recent years. Endoscopic submucosal dissection endoscopic full-thickness resection are both reported with promising results in terms of safety and short-term efficacy.

Though endoscopic resection has been suggested as one of the treatment options for gastric GISTs, No randomized controlled trial for endoscopic resection versus laparoscopic partial gastrectomy exists at this moment. This research is a prospective, multi-center trial for endoscopic resection and laparoscopic partial gastrectomy in patients with 2-5cm gastric GISTs. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of endoscopic resection compared with laparoscopic partial gastrectomy for 2-5cm gastric GISTs. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with gastric GISTs in imaging examinations including contrast-enhanced abdominal and pelvic CT, EGD examination and endoscopic ultrasound examination
  • The maximum diameter of the tumor is > 2cm and ≤ 5cm
  • No history of upper abdominal surgery (except for laparoscopic cholecystectomy)
  • No history of neoadjuvant therapy or targeted therapy
  • Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
  • Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
  • Sufficient organ functions
  • Written informed consent

Exclusion Criteria:

  • Gastric GISTs with completely extra-luminal growth pattern
  • Metastases found in preopreative examinations
  • History of simultaneous malignancies or heterochronous malignancies within 5 years
  • Women during pregnancy or breast-feeding
  • Severe heart and lung disease, severe renal insufficiency, unable to perform laparoscopic surgery
  • Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated
  • Severe mental disease
  • Severe respiratory disease
  • Severe hepatic and renal dysfunction
  • Unstable angina pectoris or history of myocardial infarction within 6 months
  • History of cerebral infarction or cerebral hemorrhage within 6 months
  • Patients with other diseases who can be surgically intervened at the same time
  • Continuous systemic steroid therapy within 1 month (except for topical use)
  • Patients are participating or have participated in another clinical trial (within 6 months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic resection
The endoscopist will perform endoscopic resection for patients enrolled in this group.
Procedure: Endoscopic resection
Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs
Other: Laparoscopic partial gastrectomy
The endoscopist will perform laparoscopic partial gastrectomy for patients enrolled in this group.
Procedure: Laparoscopic partial gastrectomy
Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early operative morbidity rate
Time Frame: 30 days
The early operative morbidity is defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications.
30 days
Early operative mortality rate
Time Frame: 30 days
The early operative mortality is defined as deaths observed within 30 days following surgery.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: intraoperative
Operation time is documented as a composite outcome measure.
intraoperative
Time to first ambulation
Time Frame: 30 days
Time to first ambulation is used to assess the postoperative recovery course, which is a composite outcome measure.
30 days
Time to first flatus
Time Frame: 30 days
Time to first flatus is used to assess the postoperative recovery course, which is a composite outcome measure.
30 days
Time to first liquid diet
Time Frame: 30 days
Time to first liquid diet is used to assess the postoperative recovery course, which is a composite outcome measure.
30 days
Time to first soft diet
Time Frame: 30 days
Time to first soft diet is used to assess the postoperative recovery course, which is a composite outcome measure.
30 days
Postoperative hospital stay
Time Frame: 30 days
The length of postoperative hospital stay will be recorded.
30 days
En bloc resection rate
Time Frame: 0, day of endoscopic surgery or laparoscopic surgery
The rate of en bloc resection in all cases will be recorded.
0, day of endoscopic surgery or laparoscopic surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Pinghong Zhou, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 15, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

January 30, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK2020-032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric GIST

Clinical Trials on Endoscopic resection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe