Back to resultsSafety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach
Primary Purpose
Gastrointestinal Stromal Tumors
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic resection
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring Gastrointestinal Stromal Tumors, Unfavorable Anatomic Site of Stomach, Laparoscopic Resection
Eligibility Criteria
Inclusion Criteria:
- Age from over 18 to under 75 years;
- Gastrointestinal stromal tumor at unfavorable anatomic sites of stomach preoperatively confirmed by endoscopy, ultrasound endoscopy, CT or MRI;
- Diameter of tumor size is ≥2cm and ≤5cm confirmed by contrast CT or MRI;
- Patients whose tumor is resectable by laparoscopic technique at preoperative assessment;
- No evidence of distant metastasis and tumor invading nearby organs at preoperative assessment;
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
- ASA (American Society of Anesthesiology) score I, II, or III;
- Written informed consent.
Exclusion Criteria:
- Women during pregnancy or breast-feeding;
- Severe mental disorder;
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy);
- History of other malignant disease within the past five years;
- History of previous neoadjuvant imatinib therapy;
- History of unstable angina or myocardial infarction within the past six months;
- History of cerebrovascular accident within the past six months;
- History of continuous systematic administration of corticosteroids within the past month;
- Requirement of simultaneous surgery for other disease;
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastrointestinal stromal tumor;
- FEV1<50% of predicted value;
- Patients with GIST locates at favorable anatomic sites detected by contrast CT, MRI or ultrasound endoscopy at preoperative assessment;
- Patients with GIST diameter<2cm or>5cm detected by contrast CT or MRI;
- Presence of distant metastasis or tumor invading nearby organs at preoperative assessment.
Withdrawal Criteria:
- Patients postoperatively confirmed as non-GIST case by pathology (These cases are enrolled in safe group for future statistic analysis);
- GIST at unfavorable anatomic site diagnosed before operation, while GIST at favorable anatomic site determined by intraoperative exploration;
- Patients confirmed as tumor rupture , metastasis or invading nearby organs intraoperately;
- Patients requiring simultaneous surgical treatment of other diseases;
- Sudden severe complications during the perioperative period (intolerable surgery or anesthesia), which renders it unsuitable or unfeasible to implement the study treatment protocol as scheduled;
- Patients confirmed to require emergency surgery by attending physicians due to changes in the patient's condition after inclusion in this study;
- Patients who voluntarily quit or discontinue treatment for personal reasons at any stage after inclusion in this study;
- Treatment implemented is proven to violate study protocol.
Sites / Locations
- Renji hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laparoscopic resection
Arm Description
laparoscopic resection for GIST at unfavorable anatomic sites of stomach
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05197933
First Posted
September 7, 2021
Last Updated
January 14, 2022
Sponsor
RenJi Hospital
Collaborators
Nanfang Hospital, Southern Medical University, Peking University Cancer Hospital & Institute, Shanghai Zhongshan Hospital, The First Affiliated Hospital with Nanjing Medical University, Fujian Medical University Union Hospital, Peking University People's Hospital, Ruijin Hospital, Wuhan Union Hospital, China, West China Hospital, First Affiliated Hospital, Sun Yat-Sen University, Liaoning Cancer Hospital & Institute, Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05197933
Brief Title
Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach
Official Title
Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach：a Multicenter Prospective Trial（CLASS-06）
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Nanfang Hospital, Southern Medical University, Peking University Cancer Hospital & Institute, Shanghai Zhongshan Hospital, The First Affiliated Hospital with Nanjing Medical University, Fujian Medical University Union Hospital, Peking University People's Hospital, Ruijin Hospital, Wuhan Union Hospital, China, West China Hospital, First Affiliated Hospital, Sun Yat-Sen University, Liaoning Cancer Hospital & Institute, Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
Gastrointestinal Stromal Tumors, Unfavorable Anatomic Site of Stomach, Laparoscopic Resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multicenter, open-label, single-arm
Masking
None (Open Label)
Masking Description
Blinding Method: Open Label
Allocation
N/A
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic resection
Arm Type
Experimental
Arm Description
laparoscopic resection for GIST at unfavorable anatomic sites of stomach
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic resection
Intervention Description
Laparoscopic resection for GIST at unfavorable anatomic site of stomach will be conducted
Primary Outcome Measure Information:
Title
3-year disease-free survival rate (DFS)
Description
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
Secondary Outcome Measure Information:
Title
Success rate of laparoscopic surgery
Description
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
Title
Rate of intraoperative complication
Description
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
Title
Rate of Postoperative complication
Description
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
Title
3-year overall survival rate (OS)
Description
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
Title
Postoperative recovery course（Time to start off-bed activities, bowel function, to restore liquid food and semi-liquid food）
Description
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
Title
Postoperative recovery course（Highest Body Temperature）
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from over 18 to under 75 years;
Gastrointestinal stromal tumor at unfavorable anatomic sites of stomach preoperatively confirmed by endoscopy, ultrasound endoscopy, CT or MRI;
Diameter of tumor size is ≥2cm and ≤5cm confirmed by contrast CT or MRI;
Patients whose tumor is resectable by laparoscopic technique at preoperative assessment;
No evidence of distant metastasis and tumor invading nearby organs at preoperative assessment;
Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
ASA (American Society of Anesthesiology) score I, II, or III;
Written informed consent.
Exclusion Criteria:
Women during pregnancy or breast-feeding;
Severe mental disorder;
History of previous upper abdominal surgery (except laparoscopic cholecystectomy);
History of other malignant disease within the past five years;
History of previous neoadjuvant imatinib therapy;
History of unstable angina or myocardial infarction within the past six months;
History of cerebrovascular accident within the past six months;
History of continuous systematic administration of corticosteroids within the past month;
Requirement of simultaneous surgery for other disease;
Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastrointestinal stromal tumor;
FEV1<50% of predicted value;
Patients with GIST locates at favorable anatomic sites detected by contrast CT, MRI or ultrasound endoscopy at preoperative assessment;
Patients with GIST diameter<2cm or>5cm detected by contrast CT or MRI;
Presence of distant metastasis or tumor invading nearby organs at preoperative assessment.
Withdrawal Criteria:
Patients postoperatively confirmed as non-GIST case by pathology (These cases are enrolled in safe group for future statistic analysis);
GIST at unfavorable anatomic site diagnosed before operation, while GIST at favorable anatomic site determined by intraoperative exploration;
Patients confirmed as tumor rupture , metastasis or invading nearby organs intraoperately;
Patients requiring simultaneous surgical treatment of other diseases;
Sudden severe complications during the perioperative period (intolerable surgery or anesthesia), which renders it unsuitable or unfeasible to implement the study treatment protocol as scheduled;
Patients confirmed to require emergency surgery by attending physicians due to changes in the patient's condition after inclusion in this study;
Patients who voluntarily quit or discontinue treatment for personal reasons at any stage after inclusion in this study;
Treatment implemented is proven to violate study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Cao, Professor
Phone
13918141425
Email
caohuishcn@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Cao, Professor
Organizational Affiliation
RenJi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Renji hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Cao, Professor
Phone
13918141425
Email
caohuishcn@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach
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