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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 : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University

Brief Summary:
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.

Condition or disease Intervention/treatment
GIST of Stomach Gastric Cancer Surgery Complication Procedure: Laparoscopic resection

Detailed Description:
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy. Main end of study: 3-year disease free survival rate

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Study Type : Observational
Estimated Enrollment : 200 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)
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : May 1, 2021


Group/Cohort Intervention/treatment
Group A (Study group)
Group for laparoscopic resection of GIST with unfavorable group (Unfavorable group)
Procedure: Laparoscopic resection
Laparoscopic surgery under general anesthesia

Group B (Control group)
Group for laparoscopic resection of GIST with favorable group (favorable group)
Procedure: Laparoscopic resection
Laparoscopic surgery under general anesthesia




Primary Outcome Measures :
  1. 3-year disease free survival rate [ Time Frame: 36 months ]

    Definition of recurrence and recurrence date The following situations are regarded as "recurrence"

    1. 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".
    2. 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".
    3. 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".
    4. A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse.


Secondary Outcome Measures :
  1. Intraoperative morbidity rates [ Time Frame: 30 days ]
    1. . 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.
    2. . Intraoperative morbidity (occurring from skin incision to skin closure) including: surgery-related morbidity: intraoperative hemorrhage and injury:

  2. Conversion to open surgery rate [ Time Frame: 30 days ]
    1. . In this study, if the length of the auxiliary incision is more than 10 cm, it is considered a conversion to open surgery.
    2. .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.

  3. Positive surgical margin rate [ Time Frame: 30 days ]
    1. . The investigators confirm the surgical margin status by postoperative pathology report.
    2. . 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.

  4. Overall postoperative serious complications rates [ Time Frame: 30 days ]
    1. . 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.
    2. . 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.


  5. 3-year overall survival rate [ Time Frame: 36 months ]
    1. The overall survival is calculated from the day of surgery until death or until the final follow-up date, whichever occurs first.
    2. 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.

  6. 3-year recurrence pattern [ Time Frame: 36 months ]

    Definition of recurrence and recurrence date The following situations are regarded as "recurrence"

    1. 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".
    2. 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".
    3. 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".
    4. A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse.

  7. Overall postoperative morbidity and mortality rates [ Time Frame: 30 days ]
    1. 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.
    2. Postoperative morbidities are divided into short-term 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.
    5. 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.

  8. Time to first ambulation [ Time Frame: 30 days ]
    Time to first ambulation in hours is used to assess the postoperative recovery course.

  9. Time to first flatus [ Time Frame: 30 days ]
    Time to first flatus in days is used to assess the postoperative recovery course.

  10. Time to first liquid diet [ Time Frame: 30 days ]
    Time to first liquid diet in days is used to assess the postoperative recovery course.

  11. Time to first soft diet [ Time Frame: 30 days ]
    Time to first soft diet in days is used to assess the postoperative recovery course.

  12. Duration of postoperative hospital stay [ Time Frame: 30 days ]
    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

  13. The variation of weight [ Time Frame: 3, 6, 9 and 12 months ]
    The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

  14. The variation of album [ Time Frame: 3, 6, 9 and 12 months ]
    The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

  15. The variation of white blood cell count [ Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days ]
    The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

  16. The variation of C-reactive protein [ Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days ]
    The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 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
Study Population
All patients who meet the inclusion criteria and not conform to the exclusion criteria are qualified for this study.
Criteria

Inclusion Criteria:

  1. Age between 18 and 75 years old
  2. 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
  3. Written informed consent
  4. Expected R0 resection by laparoscopy
  5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
  6. ASA (American Society of Anesthesiology) class I to III
  7. Maximum tumor diameter ≤10cm

Exclusion Criteria:

  1. Pregnant and lactating women
  2. Suffering from a severe mental disorder
  3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
  4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
  5. Rejection of laparoscopic resection
  6. History of other malignant disease within the past five years
  7. History of unstable angina or myocardial infarction within the past six months
  8. History of a cerebrovascular accident within the past six months
  9. History of continuous systematic administration of corticosteroids within one month
  10. Requirement of simultaneous surgery for another disease
  11. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
  12. FEV1<50% of the predicted values
  13. Maximum tumor diameter >10cm

Publications:

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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: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang-Ming Huang, Prof., Fujian Medical University:
GIST
laparoscopic resection
early complication
mortality
tumor sites
Additional relevant MeSH terms:
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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