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NCT Number: NCT03716089

Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

Changming Huang, Professor

CONTACT

[email protected]

+8613805069676

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic resection

Procedure

Laparoscopic surgery under general anesthesia

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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:
  2. 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.
  3. 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.
  4. 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.

  5. 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.
  6. 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.
  7. 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.
  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. Intraoperative tumor rupture rates

    Time frame: 1 day

    Intraoperative tumor rupture rates are used to access the oncological safety of the intervention.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2018
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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