Actively Recruiting

Age: 18Years - 75Years
All Genders
ID03716089

Comparison of Tumor Efficacy and Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Sites

Led by Fujian Medical University · Updated on 2025-04-08

250

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the safety and effectiveness of laparoscopic surgery for gastrointestinal stromal tumors (GIST) located in different parts of the stomach. Participants are divided into groups based on whether their tumor is in a favorable or unfavorable site. The study focuses on evaluating the rates of complications and mortality after surgery, as well as the 3-year disease-free survival rate. The treatment under study is laparoscopic resection of GIST performed under general anesthesia. Participants will be grouped based on tumor location into favorable or unfavorable site groups, both receiving the standard surgical therapy. The main comparison is between these two groups regarding surgical outcomes and long-term survival. The study monitors patients for at least three years after surgery. Participants will undergo laparoscopic surgery and then be closely followed for various outcomes including postoperative complications, recovery milestones like first ambulation and diet tolerance, and survival rates over three years. Researchers will collect data on tumor recurrence, surgical margins, hospital stay duration, and changes in blood markers before and after surgery. Safety and recovery are monitored for up to 30 days post-surgery, with long-term follow-up extending to 36 months.

CONDITIONS

Brief Title

Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old
  • Primary gastric lesion confirmed as gastrointestinal stromal tumor by biopsy
  • Provided written informed consent
  • Expected to have complete tumor removal (R0 resection) by laparoscopy
  • Performance status of 0 or 1 on the ECOG scale
  • ASA physical status class I to III
  • Tumor size 10 cm or less in diameter
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Severe mental disorders
  • Previous upper abdominal surgery except laparoscopic gallbladder removal
  • Previous gastric surgery including endoscopic treatments for gastric cancer
  • Refusal of laparoscopic surgery
  • Other cancers within the past five years
  • Unstable angina or heart attack within the past six months
  • Stroke within the past six months
  • Continuous corticosteroid use within one month
  • Need for surgery on another disease at the same time
  • Emergency surgery due to bleeding, obstruction, or perforation from gastric cancer
  • Lung function less than 50% predicted
  • Tumor size greater than 10 cm in diameter

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 30 days

Participants undergo laparoscopic resection of gastrointestinal stromal tumors under general anesthesia followed by immediate post-operative monitoring.

Multiple visits during hospital stay and early recovery

Long-term Monitoring

Duration - Up to 3 years

Participants are monitored for disease-free survival, recurrence, and overall survival following surgery.

Periodic visits over 36 months

Trial Site Locations

Total: 1 location

1

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors.

George D Demetri, Margaret von Mehren, Cristina R Antonescu...

https://pubmed.ncbi.nlm.nih.gov/20457867

Laparoscopic versus open gastric resections for primary gastrointestinal stromal tumors (GISTs): a size-matched comparison.

Giorgos C Karakousis, Samuel Singer, Junting Zheng...

https://pubmed.ncbi.nlm.nih.gov/21207158

A systematic review and meta-analysis comparing laparoscopic versus open gastric resections for gastrointestinal stromal tumors of the stomach.

Ye-Xin Koh, Aik-Yong Chok, Hui-Li Zheng...

https://pubmed.ncbi.nlm.nih.gov/23793362

Open versus minimally invasive resection of gastric GIST: a multi-institutional analysis of short- and long-term outcomes.

Danielle A Bischof, Yuhree Kim, Rebecca Dodson...

https://pubmed.ncbi.nlm.nih.gov/24763984

Laparoscopic versus open gastric resection for larger than 5 cm primary gastric gastrointestinal stromal tumors (GIST): a size-matched comparison.

Jianxian Lin, Changming Huang, Chaohui Zheng...

https://pubmed.ncbi.nlm.nih.gov/24853837