An interventional study of Laparoscopic resection in Gastrointestinal Stromal Tumors, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
The aim of this trial is to evaluate the safety of laparoscopic resection for GIST whose diameter is ≥2cm and ≤5cm at unfavorable anatomic sites of stomach.
The aim of this trial is to evaluate the safety of laparoscopic resection for GIST whose diameter is ≥2cm and ≤5cm at unfavorable anatomic sites of stomach. Unfavorable anatomic sites are defined by soft tissue sarcoma, NCCN Clinical Practice Guidelines in Oncology (version 2. 2018). The defined laparoscopy unfavorable sites including the anatomic sites of stomach other than greater curvature and front wall, including the less curvature, the posterior wall, and adjacent to cardia and pylorus.
345 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 60 are open to participants now.
This study's planned enrollment of 182 is above the median of 50 across 253 interventional studies indexed under Gastrointestinal Stromal Tumors.
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Exclusion Criteria:
Withdrawal Criteria:
laparoscopic resection for GIST at unfavorable anatomic sites of stomach
Procedure: Laparoscopic resection
Laparoscopic resection for GIST at unfavorable anatomic site of stomach will be conducted
3-year disease-free survival rate (DFS)
The number of patients with DFS \> 3 years was used as the numerator and the number of all patients was used as the denominator to calculate the ratio value.
Time frame: until the date of first documented progression, assessed up to 3 years
Success rate of laparoscopic surgery
The proportion value will be calculated for the number of patients receiving laparoscopic local resection for GIST locating at unfavorable sites of stomach and meet the following 4 criteria as the numerator and the number of all patient undergo surgical treatment (laparoscopic surgery/laparotomy) as the denominator. Definition of successful laparoscopic resection： 。① Resection is completed by total laparoscopy (extra auxiliary incision is not required. Tumor is extracted through the extended trocar incision)；②Tumor is completely resected without rupture which complys with the principle of tumor isolation；③No conversion from laparoscopy to laparotomy due to incidences that laparascopy can not complete, including hemorrhage, unresectable tumor etc；④Resected margin confirmed to be negative by postoperative pathology. All the previous 4 criteria have to be achieved simultaneously to be considered a complete laparoscopic surgery.
Time frame: postoperative 15 days
Rate of intraoperative complication
The proportion value will be calculated for the number of patients with any intraoperative complication as the numerator and the number of all patients undergoing surgical treatment (laparoscopic surgery/laparotomy) as the denominator.
Time frame: intraoperative time
Rate of Postoperative complication
The proportion value will be calculated for the number of patients with any postoperative complication as the numerator and the number of all patients undergoing surgical treatment (laparoscopic surgery/laparotomy) as the denominator.
Time frame: postoperative 30 days, or the discharge day if hospitalization>30 days
3-year overall survival rate (OS)
The number of patients with OS \> 3 years was used as the numerator and the number of all patients was used as the denominator to calculate the ratio value.
Time frame: until the date of first documented progression, assessed up to 3 years
Postoperative recovery course（Time to start off-bed activities, bowel function, to restore liquid food and semi-liquid food）
Time to start off-bed activities, bowel function, to restore liquid food and semi-liquid food * Starting from the postoperative day 1 to the first postoperative discharge, within the initial recognition of the earliest time for off-bed activities, bowel function (flatulence/bowel movement), to restoration of fluid/semi-fluid diet; records are made hourly. * Flatulence/bowel movement on the day of surgery is excluded. * In case of no off-bed activities/flatulence/bowel movement/restoration of liquid/semi-liquid diet before the first postoperative discharge, the discharge time should be recorded as the time of off-bed activities/flatulence/bowel movement/restoration of liquid/semi-liquid diet. * The initial time of off-bed activities/flatulence/bowel movement/restoration of liquid/semi-liquid diet is per patient report.
Time frame: postoperative 30 days, or the discharge day if hospitalization>30 days
Postoperative recovery course（Highest Body Temperature）
Highest Body Temperature • The highest body temperature starting from postoperative day 1 up to day 3 should be measured at least three times a day.
Time frame: postoperative 3 days
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This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Gastrointestinal Stromal Tumors →