What is this study trying to find out about gastrointestinal stromal tumors?

This study is exploring the safety of laparoscopic surgery to remove gastric gastrointestinal stromal tumors (GIST), especially those 5 cm or larger. Researchers want to understand how this approach compares to surgery for smaller tumors regarding complications after surgery. The study is led by Fujian Medical University and involves multiple centers.

Who may be eligible for this gastrointestinal stromal tumor clinical trial?

Adults between 18 and 75 years with a primary gastric GIST diagnosis confirmed by biopsy or imaging may be eligible. Participants must be willing to have laparoscopic surgery and have a good general health status. Women who are pregnant or breastfeeding, or those with recent serious medical conditions, are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this gastrointestinal stromal tumor clinical trial?

Study-related care, including the surgery and all trial visits, is provided at no cost. However, personal travel expenses or other costs related to participation may vary and are not guaranteed to be covered. Participants can plan accordingly for their own expenses.

Actively Recruiting

Age: 18Years - 75Years

All Genders

ID05938309

Safety and Effectiveness of Laparoscopic Surgery for Gastric Gastrointestinal Stromal Tumors 5cm and Larger A Multicenter Prospective Cohort Study

Led by Fujian Medical University · Updated on 2023-07-10

194

Participants Needed

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the safety of laparoscopic surgery to remove gastric gastrointestinal stromal tumors GIST that are 5 cm or larger. This prospective, multicenter cohort study aims to compare the clinical outcomes of laparoscopic resection of large gastric GISTs with those of smaller tumors less than 5 cm. The main focus is to evaluate overall postoperative complications within 30 days after surgery or upon discharge if the hospital stay is longer. The study involves two groups patients undergoing laparoscopic removal of gastric GISTs 5 cm or larger, and those with tumors smaller than 5 cm receiving the same procedure. The laparoscopic approach is expected to achieve complete tumor removal R0 resection. Various postoperative measures will be observed, including rates of complications during and after surgery, conversion to open surgery, surgical margin status, and changes in blood tests such as white blood cell count, hemoglobin, and C-reactive protein. Participants will be closely monitored after surgery through assessments of recovery milestones like time to first movement, bowel function, diet progression, and duration of hospital stay. Long-term outcomes including 3-year overall survival, disease-free survival, and recurrence patterns will also be recorded. The total follow-up spans up to 36 months, with detailed postoperative evaluations conducted up to 30 days and blood tests monitored before and after surgery at specified intervals.

CONDITIONS

Brief Title

A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 18 and 75 years
Primary gastric lesion diagnosed as gastric GIST by endoscopic biopsy or suspected by endoscopy, ultrasound, CT, or MRI, confirmed by postoperative pathology
Patient gives informed consent and agrees to laparoscopic resection
Expected to achieve complete tumor removal (R0 resection) by laparoscopy
Performance status: ECOG score 2 or less, ASA score I-III before surgery

You will not qualify if you...

Women who are pregnant or breastfeeding
Severe mental disorders
History of upper abdominal surgery except laparoscopic gallbladder removal
History of gastric surgery except endoscopic submucosal dissection or mucosal resection for gastric cancer
History of other cancers within the past five years
History of unstable angina or heart attack within the past six months
History of stroke within the past six months
Continuous corticosteroid use within one month
Need for simultaneous surgery for other diseases
Emergency surgery due to complications from gastric cancer such as bleeding, obstruction, or perforation

Research Team

Ping Li, MD，PhD

Linghua Wei

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