Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site
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ClinicalTrials.gov Identifier: NCT03716089 |
Recruitment Status :
Recruiting
First Posted : October 23, 2018
Last Update Posted : June 22, 2023
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Condition or disease | Intervention/treatment |
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GIST of Stomach Gastric Cancer Surgery Complication | Procedure: Laparoscopic resection |
Study Type : | Observational |
Estimated Enrollment : | 246 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site(FUGES-016) |
Actual Study Start Date : | October 11, 2018 |
Estimated Primary Completion Date : | August 1, 2023 |
Estimated Study Completion Date : | October 1, 2025 |
Group/Cohort | Intervention/treatment |
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Group A (Study group)
Group for laparoscopic resection of GIST with unfavorable group (Unfavorable group)
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Procedure: Laparoscopic resection
Laparoscopic surgery under general anesthesia |
Group B (Control group)
Group for laparoscopic resection of GIST with favorable group (favorable group)
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Procedure: Laparoscopic resection
Laparoscopic surgery under general anesthesia |
- 3-year disease free survival rate [ Time Frame: 36 months ]
Definition of recurrence and recurrence date The following situations are regarded as "recurrence"
- Recurrence identified by any one image examination (X-ray, ultrasound, computed tomography, magnetic resonance imaging, etc.) and, if there are a variety of imaging examinations, results without contradiction determined "recurrence". The earliest date that the recurrence is found is defined as the "recurrence date".
- For cases that lack the use of imaging or a pathological diagnosis, the date of diagnosing the occurrence of clinical recurrence based on clinical history and physical examination is defined as the "recurrence date".
- For cases without imaging or clinical diagnosis but with a cytology or tissue biopsy pathological diagnosis of recurrence, the earliest date confirmed by cytology or biopsy pathology is considered the "recurrence date".
- A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse.
- Intraoperative morbidity rates [ Time Frame: 30 days ]
- . The number of all patients treated with surgery as the denominator and the number of the patients with any intraoperative morbidity as the numerator are used to calculate the proportions.
- . Intraoperative morbidity (occurring from skin incision to skin closure) including: surgery-related morbidity: intraoperative hemorrhage and injury:
- Conversion to open surgery rate [ Time Frame: 30 days ]
- . In this study, if the length of the auxiliary incision is more than 10 cm, it is considered a conversion to open surgery.
- .The number of all patients treated with surgery as the denominator and the number of the patients with conversion to open surgery as the numerator are used to calculate the proportions.
- Positive surgical margin rate [ Time Frame: 30 days ]
- . The investigators confirm the surgical margin status by postoperative pathology report.
- . The number of all patients treated with surgery as the denominator and the number of the patients with positive surgical margin as the numerator are used to calculate the proportions.
- Overall postoperative serious complications rates [ Time Frame: 30 days ]
- . Incidence of postoperative major complications: The standard for postoperative major complications refers to the short-term complications according to the Clavien-dindo grade, IIIA level and above for serious complications, and when multiple complications occur simultaneously, the highest ranked complication is the subject.
- . Postoperative complications are divided into short-term complications after surgery and long-term complications after surgery. (3)Short-term is defined as within 30 days of surgery or the first discharge if the hospital stay is > 30 days.
(4)Long-term is defined as the period from 30 days or more after the operation or the period between first discharge (the hospital days after surgery >30 days) and 3 years after the operation.
- 3-year overall survival rate [ Time Frame: 36 months ]
- The overall survival is calculated from the day of surgery until death or until the final follow-up date, whichever occurs first.
- For survival cases, the end point is the last date that survival was confirmed. If loss to follow-up occurred, the end point is the final date that survival could be confirmed.
- 3-year recurrence pattern [ Time Frame: 36 months ]
Definition of recurrence and recurrence date The following situations are regarded as "recurrence"
- Recurrence identified by any one image examination (X-ray, ultrasound, computed tomography, magnetic resonance imaging, etc.) and, if there are a variety of imaging examinations, results without contradiction determined "recurrence". The earliest date that the recurrence is found is defined as the "recurrence date".
- For cases that lack the use of imaging or a pathological diagnosis, the date of diagnosing the occurrence of clinical recurrence based on clinical history and physical examination is defined as the "recurrence date".
- For cases without imaging or clinical diagnosis but with a cytology or tissue biopsy pathological diagnosis of recurrence, the earliest date confirmed by cytology or biopsy pathology is considered the "recurrence date".
- A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse.
- Overall postoperative morbidity and mortality rates [ Time Frame: 30 days ]
- The number of all patients treated with surgery as the denominator and the number of the patients with any intraoperative and postoperative morbidity and mortality as the numerator are used to calculate the proportions.
- Postoperative morbidities are divided into short-term and long-term complications after surgery.
- Short-term is defined as within 30 days of surgery or the first discharge if the hospital stay is > 30 days.
- Long-term is defined as the period from 30 days or more after the operation or the period between first discharge (the hospital days after surgery >30 days) and 3 years after the operation.
- Postoperative mortality: patients whose death was identified according to documented intraoperative observation items, including patients who die within 30 days after surgery (including the 30th day) regardless of the causality between death and surgery, and patients who die more than 30 days after surgery.
- Time to first ambulation [ Time Frame: 30 days ]Time to first ambulation in hours is used to assess the postoperative recovery course.
- Time to first flatus [ Time Frame: 30 days ]Time to first flatus in days is used to assess the postoperative recovery course.
- Time to first liquid diet [ Time Frame: 30 days ]Time to first liquid diet in days is used to assess the postoperative recovery course.
- Time to first soft diet [ Time Frame: 30 days ]Time to first soft diet in days is used to assess the postoperative recovery course.
- Duration of postoperative hospital stay [ Time Frame: 30 days ]Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
- Intraoperative tumor rupture rates [ Time Frame: 1 day ]Intraoperative tumor rupture rates are used to access the oncological safety of the intervention.
- The variation of album [ Time Frame: Preoperative 7 days and postoperative 1 and 5 days ]The variation of album in gram/liter on preoperative 7 days and postoperative 1 and 5 days are used to access the postoperative nutritional status and quality of life.
- The variation of hemoglobin [ Time Frame: Preoperative 7 days and postoperative 1 and 5 days ]The variation of hemoglobin in gram/liter on preoperative 7 days and postoperative 1 and 5 days are used to access the postoperative nutritional status and quality of life.
- The variation of white blood cell count [ Time Frame: Preoperative 7 days and postoperative 1 and 5 days ]The values of white blood cell count from peripheral blood preoperative 7 days and postoperative 1 and 5 days are recorded to access the inflammatory and immune response.
- The variation of C-reactive protein [ Time Frame: Preoperative 7 days and postoperative 1 and 5 days ]The values of C-reactive protein IN milligram/liter from peripheral blood preoperative 7 days and postoperative 1 and 5 days are recorded to access the inflammatory and immune response.
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age between 18 and 75 years old
- Primary gastric lesion confirmed pathologically GIST by endoscopic biopsy. Preoperative endoscopy, ultrasound endoscopy or computer tomography, Magnetic resonance suspected GIST, and then postoperative pathology confirmed as the original GIST
- Written informed consent
- Expected R0 resection by laparoscopy
- Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Maximum tumor diameter ≤10cm
Exclusion Criteria:
- Pregnant and lactating women
- Suffering from a severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR for gastric cancer)
- Rejection of laparoscopic resection
- History of other malignant disease within the past five years
- History of unstable angina or myocardial infarction within the past six months
- History of a cerebrovascular accident within the past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for another disease
- Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
- Maximum tumor diameter >10cm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716089
China, Fujian | |
Fujian Medical University Union Hospital | Recruiting |
Fuzhou, Fujian, China, 350001 | |
Contact: Changming Huang, Professor +8613805069676 hcmlr2002@163.com |
Responsible Party: | Chang-Ming Huang, Prof., Professor, Fujian Medical University |
ClinicalTrials.gov Identifier: | NCT03716089 |
Other Study ID Numbers: |
FUGES-016 |
First Posted: | October 23, 2018 Key Record Dates |
Last Update Posted: | June 22, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
GIST laparoscopic resection early complication mortality tumor sites |
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |