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

NCT03716089 | Recruiting

• 1 other identifier: FUGES-016
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GIST of Stomach; Gastric Cancer; Surgery; Complication

Keywords

GIST; laparoscopic resection; early complication; mortality; tumor sites

Outcome Measures

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.

  36 months

Secondary Outcomes (17)

• Intraoperative morbidity rates

  30 days

• Conversion to open surgery rate

  30 days

• Positive surgical margin rate

  30 days

• Overall postoperative serious complications rates

  30 days

• 3-year overall survival rate

  36 months

Study Arms (2)

Group A (Study group)

Group for laparoscopic resection of GIST with unfavorable group (Unfavorable group)

Procedure: Laparoscopic resection

Group B (Control group)

Group for laparoscopic resection of GIST with favorable group (favorable group)

Procedure: Laparoscopic resection

Interventions

Laparoscopic resection PROCEDURE

Laparoscopic surgery under general anesthesia

Group A (Study group); Group B (Control group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Related Publications (18)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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.

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  PMID: 23233005 BACKGROUND

• 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.

  PMID: 24763984 BACKGROUND

• Lin J, Huang C, Zheng C, Li P, Xie J, Wang J, Lu J. Laparoscopic versus open gastric resection for larger than 5 cm primary gastric gastrointestinal stromal tumors (GIST): a size-matched comparison. Surg Endosc. 2014 Sep;28(9):2577-83. doi: 10.1007/s00464-014-3506-x. Epub 2014 May 23.

  PMID: 24853837 BACKGROUND

• Honda M, Hiki N, Nunobe S, Ohashi M, Kiyokawa T, Sano T, Yamaguchi T. Long-term and surgical outcomes of laparoscopic surgery for gastric gastrointestinal stromal tumors. Surg Endosc. 2014 Aug;28(8):2317-22. doi: 10.1007/s00464-014-3459-0. Epub 2014 Feb 25.

  PMID: 24566748 BACKGROUND

• Masoni L, Gentili I, Maglio R, Meucci M, D'Ambra G, Di Giulio E, Di Nardo G, Corleto VD. Laparoscopic resection of large gastric GISTs: feasibility and long-term results. Surg Endosc. 2014 Oct;28(10):2905-10. doi: 10.1007/s00464-014-3552-4. Epub 2014 May 31.

  PMID: 24879133 BACKGROUND

• Hsiao CY, Yang CY, Lai IR, Chen CN, Lin MT. Laparoscopic resection for large gastric gastrointestinal stromal tumor (GIST): intermediate follow-up results. Surg Endosc. 2015 Apr;29(4):868-73. doi: 10.1007/s00464-014-3742-0. Epub 2014 Jul 23.

  PMID: 25052129 BACKGROUND

• Chen K, Zhou YC, Mou YP, Xu XW, Jin WW, Ajoodhea H. Systematic review and meta-analysis of safety and efficacy of laparoscopic resection for gastrointestinal stromal tumors of the stomach. Surg Endosc. 2015 Feb;29(2):355-67. doi: 10.1007/s00464-014-3676-6. Epub 2014 Jul 9.

  PMID: 25005014 BACKGROUND

• Dressler JA, Palazzo F, Berger AC, Stake S, Chaudhary A, Chojnacki KA, Rosato EL, Pucci MJ. Long-term functional outcomes of laparoscopic resection for gastric gastrointestinal stromal tumors. Surg Endosc. 2016 Apr;30(4):1592-8. doi: 10.1007/s00464-015-4384-6. Epub 2015 Jul 14.

  PMID: 26169640 BACKGROUND

• Nguyen SQ, Divino CM, Wang JL, Dikman SH. Laparoscopic management of gastrointestinal stromal tumors. Surg Endosc. 2006 May;20(5):713-6. doi: 10.1007/s00464-005-0435-8. Epub 2006 Feb 21.

  PMID: 16502196 BACKGROUND

• Poskus E, Petrik P, Petrik E, Lipnickas V, Stanaitis J, Strupas K. Surgical management of gastrointestinal stromal tumors: a single center experience. Wideochir Inne Tech Maloinwazyjne. 2014 Mar;9(1):71-82. doi: 10.5114/wiitm.2014.40987. Epub 2014 Feb 26.

  PMID: 24729813 BACKGROUND

• Huang CM, Chen QF, Lin JX, Lin M, Zheng CH, Li P, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Tu RH. Can laparoscopic surgery be applied in gastric gastrointestinal stromal tumors located in unfavorable sites?: A study based on the NCCN guidelines. Medicine (Baltimore). 2017 Apr;96(14):e6535. doi: 10.1097/MD.0000000000006535.

  PMID: 28383420 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 23, 2018
• Study Start: October 11, 2018
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)