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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFujian Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

All patients who meet the inclusion criteria and not conform to the exclusion criteria are qualified for this study.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Laparoscopic resection

    Procedure/Surgery

    Laparoscopic surgery under general anesthesia

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Group A (Study group)1 intervention
Group B: Group B (Control group)1 intervention

Trial outcomes

Primary outcomes

1

3-year disease free survival rate

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.

Time frame
36 months

Secondary outcomes

1

Intraoperative morbidity rates

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:

Time frame
30 days
2

Conversion to open surgery rate

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.

Time frame
30 days
3

Positive surgical margin rate

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.

Time frame
30 days
4

Overall postoperative serious complications rates

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.

Time frame
30 days

Other outcomes

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