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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic resection | Experimental | laparoscopic resection for GIST at unfavorable anatomic sites of stomach |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic resection | Procedure | Laparoscopic resection for GIST at unfavorable anatomic site of stomach will be conducted |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | until the date of first documented progression, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Cao, Professor | Contact | 13918141425 | caohuishcn@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui Cao, Professor | RenJi Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 1, 2021 | Dec 11, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| The First Affiliated Hospital with Nanjing Medical University |
| OTHER |
| Fujian Medical University Union Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| West China Hospital | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| Chinese PLA General Hospital | OTHER |
Prospective, multicenter, open-label, single-arm
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Blinding Method: Open Label
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| 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. | 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. | 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. | 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
| 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. | postoperative 3 days |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |