Clinical trial NCT05938309: A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors
Official title: A Prospective, Multicenter Cohort Study on the Efficacy and Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Stromal Tumors
Keywords: Gastrectomy
Laparoscopic
gastrointestinal stromal tumor
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Fujian Provincial Hospital
name: Fujian Cancer Hospital
name: First Affiliated Hospital of Fujian Medical University
name: 900 Hospital of Joint Logistics Support Force of PLA
name: The First Affiliated Hospital of Xiamen University
name: The Second Affiliated Hospital of Fujian Medical University
name: The First Hospital of Putian City
name: The Affiliated Hospital(Group) of Putian University
name: Zhangzhou Municipal Hospital of Fujian Province
name: Longyan City First Hospital
First posted: 2023-07-10
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are assigned to undergo gastrectomy for gastric gastrointestinal stromal tumors are included.

Brief summary: The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors

Detailed description: There is a lack of high-quality evidence on the efficacy and safety of laparoscopic resection of gastric GIST over 5cm. A multicenter, prospective cohort study was conducted to evaluate the clinical efficacy of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors (GIST) compared to laparoscopic resection of GIST of less than 5cm. The primary evaluation parameter is overall postoperative morbidity.

Eligibility criteria: Inclusion Criteria:

1. 18 years \< age \< 75 years
2. Primary gastric lesion diagnosed as gastric GSIT by endoscopic biopsy histopathology or suspected gastric GIST by preoperative endoscopy, ultrasound endoscopy, or CT or MR, and confirmed as primary gastric GIST by postoperative pathology
3. Patient informed consent and willingness to undergo laparoscopic resection
4. Expected laparoscopic outcome of R0 resection
5. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists（ASA） score I-III

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of upper abdominal surgery (except the history of laparoscopic cholecystectomy)
4. History of gastric surgery (except ESD/EMR for gastric cancer)
5. History of other malignant diseases within the past five years
6. History of unstable angina or myocardial infarction within the past six months
7. History of a cerebrovascular accident within the past six months
8. History of continuous systematic administration of corticosteroids within one month
9. Requirement of simultaneous surgery for other diseases
10. Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer

Primary outcomes:
measure: Overall postoperative morbidity
timeFrame: 30 days after surgery or the first discharge ( if over 30 days hospital stay)
Secondary outcomes:
measure: intraoperative morbidity rates
timeFrame: 1 day
measure: Conversion to open surgery rate
timeFrame: 1 day
measure: Positive surgical margin rate
timeFrame: 1 day
measure: The variation of white blood cell count
timeFrame: Preoperative 7 days and postoperative 1, 3, and 5 days
measure: The variation of hemoglobin
timeFrame: Preoperative 7 days and postoperative 1, 3, and 5 days
measure: The variation of C-reactive protein
timeFrame: Preoperative 7 days and postoperative 1, 3, and 5 days
measure: overall postoperative serious morbidity rates
timeFrame: 30 days after surgery or the first discharge ( if over 30 days hospital stay)
measure: Time to first ambulation
timeFrame: 30 days
measure: Time to first flatus
timeFrame: 30 days
measure: Time to first liquid diet
timeFrame: 30 days
measure: Time to first soft diet
timeFrame: 30 days
measure: Duration of postoperative hospital stay
timeFrame: 30 days
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Gastric Surgery， Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
citation: Joensuu H, Hohenberger P, Corless CL. Gastrointestinal stromal tumour. Lancet. 2013 Sep 14;382(9896):973-83. doi: 10.1016/S0140-6736(13)60106-3. Epub 2013 Apr 24.
citation: Dematteo RP, Gold JS, Saran L, Gonen M, Liau KH, Maki RG, Singer S, Besmer P, Brennan MF, Antonescu CR. Tumor mitotic rate, size, and location independently predict recurrence after resection of primary gastrointestinal stromal tumor (GIST). Cancer. 2008 Feb 1;112(3):608-15. doi: 10.1002/cncr.23199.
citation: Bischof DA, Kim Y, Dodson R, Carolina Jimenez M, Behman R, Cocieru A, Blazer DG 3rd, Fisher SB, Squires MH 3rd, Kooby DA, Maithel SK, Groeschl RT, Clark Gamblin T, Bauer TW, Karanicolas PJ, Law C, Quereshy FA, Pawlik TM. Open versus minimally invasive resection of gastric GIST: a multi-institutional analysis of short- and long-term outcomes. Ann Surg Oncol. 2014 Sep;21(9):2941-8. doi: 10.1245/s10434-014-3733-3. Epub 2014 Apr 24.
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