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Recruiting NCT03716089

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

— Observational GIST of Stomach Gastric Cancer Surgery Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic resection.
Who it may be relevant to
Registry conditions: GIST of Stomach, Gastric Cancer, Surgery, Complication. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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）

Overview

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.

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

Interventions

  • Procedure Laparoscopic resection
    Laparoscopic surgery under general anesthesia

Primary outcome measures

  • 3-year disease free survival rate [Time frame: 36 months]
Secondary outcome measures (12)
  • Intraoperative morbidity rates [Time frame: 30 days]
  • Conversion to open surgery rate [Time frame: 30 days]
  • Positive surgical margin rate [Time frame: 30 days]
  • Overall postoperative serious complications rates [Time frame: 30 days]
  • 3-year overall survival rate [Time frame: 36 months]
  • 3-year recurrence pattern [Time frame: 36 months]
  • Overall postoperative morbidity and mortality rates [Time frame: 30 days]
  • Time to first ambulation [Time frame: 30 days]
  • Time to first flatus [Time frame: 30 days]
  • Time to first liquid diet [Time frame: 30 days]
  • Time to first soft diet [Time frame: 30 days]
  • Duration of postoperative hospital stay [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Fujian Medical University Union Hospital — Fuzhou

Publications

  • Pidhorecky I, Cheney RT, Kraybill WG, Gibbs JF. Gastrointestinal stromal tumors: current diagnosis, biologic behavior, and management. Ann Surg Oncol. 2000 Oct;7(9):705-12. doi: 10.1007/s10434-000-0705-6. PMID 11034250
  • Demetri GD, von Mehren M, Antonescu CR, DeMatteo RP, Ganjoo KN, Maki RG, Pisters PW, Raut CP, Riedel RF, Schuetze S, Sundar HM, Trent JC, Wayne JD. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010 Apr;8 Suppl 2(0 2):S1-41; quiz S42-4. doi: 10.6004/jnccn.2010.0116. PMID 20457867
  • Miettinen M, Majidi M, Lasota J. Pathology and diagnostic criteria of gastrointestinal stromal tumors (GISTs): a review. Eur J Cancer. 2002 Sep;38 Suppl 5:S39-51. doi: 10.1016/s0959-8049(02)80602-5. PMID 12528772
  • Karakousis GC, Singer S, Zheng J, Gonen M, Coit D, DeMatteo RP, Strong VE. Laparoscopic versus open gastric resections for primary gastrointestinal stromal tumors (GISTs): a size-matched comparison. Ann Surg Oncol. 2011 Jun;18(6):1599-605. doi: 10.1245/s10434-010-1517-y. Epub 2011 Jan 5. PMID 21207158
  • Melstrom LG, Phillips JD, Bentrem DJ, Wayne JD. Laparoscopic versus open resection of gastric gastrointestinal stromal tumors. Am J Clin Oncol. 2012 Oct;35(5):451-4. doi: 10.1097/COC.0b013e31821954a7. PMID 21552096
  • Koh YX, Chok AY, Zheng HL, Tan CS, Chow PK, Wong WK, Goh BK. A systematic review and meta-analysis comparing laparoscopic versus open gastric resections for gastrointestinal stromal tumors of the stomach. Ann Surg Oncol. 2013 Oct;20(11):3549-60. doi: 10.1245/s10434-013-3051-1. Epub 2013 Jun 21. PMID 23793362
  • Ganai S, Prachand VN, Posner MC, Alverdy JC, Choi E, Hussain M, Waxman I, Patti MG, Roggin KK. Predictors of unsuccessful laparoscopic resection of gastric submucosal neoplasms. J Gastrointest Surg. 2013 Feb;17(2):244-55; discussion 255-6. doi: 10.1007/s11605-012-2095-z. Epub 2012 Dec 8. PMID 23225195
  • De Vogelaere K, Hoorens A, Haentjens P, Delvaux G. Laparoscopic versus open resection of gastrointestinal stromal tumors of the stomach. Surg Endosc. 2013 May;27(5):1546-54. doi: 10.1007/s00464-012-2622-8. Epub 2012 Dec 12. PMID 23233005

Identifiers

NCT: NCT03716089 · FUGES-016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗