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Trial Title:
A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors
NCT ID:
NCT05938309
Condition:
Gastrointestinal Stromal Tumors
Conditions: Official terms:
Gastrointestinal Stromal Tumors
Conditions: Keywords:
Gastrectomy
Laparoscopic
gastrointestinal stromal tumor
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
The purpose of this study is to explore the safety of laparoscopic resection of 5cm or
larger gastric gastrointestinal stromal tumors
Detailed description:
There is a lack of high-quality evidence on the efficacy and safety of laparoscopic
resection of gastric GIST over 5cm. A multicenter, prospective cohort study was conducted
to evaluate the clinical efficacy of laparoscopic resection of 5cm or larger gastric
gastrointestinal stromal tumors (GIST) compared to laparoscopic resection of GIST of less
than 5cm. The primary evaluation parameter is overall postoperative morbidity.
Criteria for eligibility:
Study pop:
Patients who are assigned to undergo gastrectomy for gastric gastrointestinal stromal
tumors are included.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. 18 years < age < 75 years
2. Primary gastric lesion diagnosed as gastric GSIT by endoscopic biopsy histopathology
or suspected gastric GIST by preoperative endoscopy, ultrasound endoscopy, or CT or
MR, and confirmed as primary gastric GIST by postoperative pathology
3. Patient informed consent and willingness to undergo laparoscopic resection
4. Expected laparoscopic outcome of R0 resection
5. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative
American Society of Anesthesiologists（ASA） score I-III
Exclusion Criteria:
1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of upper abdominal surgery (except the history of laparoscopic
cholecystectomy)
4. History of gastric surgery (except ESD/EMR for gastric cancer)
5. History of other malignant diseases within the past five years
6. History of unstable angina or myocardial infarction within the past six months
7. History of a cerebrovascular accident within the past six months
8. History of continuous systematic administration of corticosteroids within one month
9. Requirement of simultaneous surgery for other diseases
10. Emergency surgery due to complications (bleeding, obstruction, or perforation)
caused by gastric cancer
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Gastric Surgery， Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Changming Huang, MD
Phone:
+8613805069676
Email:
hcmlr2002@163.com
Start date:
May 1, 2023
Completion date:
May 1, 2028
Lead sponsor:
Agency:
Fujian Medical University
Agency class:
Other
Collaborator:
Agency:
Fujian Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Fujian Medical University
Agency class:
Other
Collaborator:
Agency:
900 th Hospital of Joint Logistics Support Force
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Fujian Medical University
Agency class:
Other
Collaborator:
Agency:
The First Hospital of Putian City
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital(Group) of Putian University
Agency class:
Other
Collaborator:
Agency:
Zhangzhou Municipal Hospital of Fujian Province
Agency class:
Other
Collaborator:
Agency:
Longyan City First Hospital
Agency class:
Other
Source:
Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05938309
