Gastrointestinal stromal tumour.
Heikki Joensuu, Peter Hohenberger, Christopher L Corless
https://pubmed.ncbi.nlm.nih.gov/23623056Actively Recruiting
Age: 18Years - 75Years
All Genders
ID05938309
A Prospective, Multicenter Cohort Study on the Efficacy and Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors
Led by Fujian Medical University · Updated on 2023-07-10
194
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
Fujian Medical University
Lead Sponsor
F
Fujian Provincial Hospital
Collaborating Sponsor
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
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
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 - Hospital stay up to 30 days
Participants undergo laparoscopic resection of gastric gastrointestinal stromal tumors followed by immediate post-operative monitoring.
Daily visits during hospital stay
Post-operative Follow-up
Duration - Up to 36 months
Participants are followed up to monitor recovery and assess overall morbidity, survival, and recurrence.
Scheduled visits up to 36 months after surgery
Trial Site Locations
Total: 1 location
1
Department of Gastric Surgery， Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Actively Recruiting
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Research Team
P
Ping Li, MD，PhD
L
Linghua Wei
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
Tumor mitotic rate, size, and location independently predict recurrence after resection of primary gastrointestinal stromal tumor (GIST).
Ronald P Dematteo, Jason S Gold, Lisa Saran...
https://pubmed.ncbi.nlm.nih.gov/18076015Open 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/24763984Laparoscopic versus open resection of gastrointestinal stromal tumors of the stomach.
Kristel De Vogelaere, Anne Hoorens, Patrick Haentjens...
https://pubmed.ncbi.nlm.nih.gov/23233005Outcome after laparoscopic versus open wedge resection for suspected gastric gastrointestinal stromal tumors: A matched-pair case-control study.
B K P Goh, Y-C Goh, A K H Eng...
https://pubmed.ncbi.nlm.nih.gov/25913060Gastrointestinal stromal tumors, version 2.2014.
Margaret von Mehren, R Lor Randall, Robert S Benjamin...
https://pubmed.ncbi.nlm.nih.gov/24925196Impact of the introduction of laparoscopic wedge resection as a surgical option for suspected small/medium-sized gastrointestinal stromal tumors of the stomach on perioperative and oncologic outcomes.
Brian K P Goh, Pierce K H Chow, Aik-Yong Chok...
https://pubmed.ncbi.nlm.nih.gov/20407770Laparoscopic Versus Open Surgery for Gastric Gastrointestinal Stromal Tumors: What Is the Impact on Postoperative Outcome and Oncologic Results?
Guillaume Piessen, Jérémie H Lefèvre, Magalie Cabau...
https://pubmed.ncbi.nlm.nih.gov/26583673Laparoscopic wedge resection for suspected large (≥5 cm) gastric gastrointestinal stromal tumors.
Chun Yuet Khoo, Brian K P Goh, Alvin K H Eng...
https://pubmed.ncbi.nlm.nih.gov/27631317Early experience of laparoscopic resection and comparison with open surgery for gastric gastrointestinal stromal tumor: a multicenter retrospective study.
Shin-Hoo Park, Hyuk-Joon Lee, Min-Chan Kim...
https://pubmed.ncbi.nlm.nih.gov/35145127