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

April 7, 2025 updated by: Chang-Ming Huang, Prof., Fujian Medical University

Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site（FUGES-016）

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first ambulation
Time Frame: 30 days
Time to first ambulation in hours is used to assess the postoperative recovery course.
30 days
Time to first flatus
Time Frame: 30 days
Time to first flatus in days is used to assess the postoperative recovery course.
30 days
Time to first liquid diet
Time Frame: 30 days
Time to first liquid diet in days is used to assess the postoperative recovery course.
30 days
Time to first soft diet
Time Frame: 30 days
Time to first soft diet in days is used to assess the postoperative recovery course.
30 days
Duration of postoperative hospital stay
Time Frame: 30 days
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
30 days
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:
30 days
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.
30 days
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.
30 days
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.
30 days
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.
36 months
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.
36 months
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.
30 days
Intraoperative tumor rupture rates
Time Frame: 1 day
Intraoperative tumor rupture rates are used to access the oncological safety of the intervention.
1 day
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.
Preoperative 7 days and postoperative 1 and 5 days
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.
Preoperative 7 days and postoperative 1 and 5 days
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.
Preoperative 7 days and postoperative 1 and 5 days
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.
Preoperative 7 days and postoperative 1 and 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2018

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

October 14, 2018

First Submitted That Met QC Criteria

October 20, 2018

First Posted (Actual)

October 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUGES-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Laparoscopic resection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe