Clinical trial · Interventional
Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor
Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Endoscopic Resection And Laparoscopic Partial Gastrectomy In Patients With 2-5cm Gastric Gastrointestinal Stromal Tumor
NCT04751591CI-TRIAL-00055302unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research is a prospective, multi-center trial for endoscopic resection and laparoscopic partial gastrectomy in patients with 2-5cm gastric gastrointestinal stromal tumor. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of endoscopic resection compared with laparoscopic partial gastrectomy for 2-5cm gastric gastrointestinal stromal tumor. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric GIST | Gastric Gastrointestinal Stromal Tumor | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic resection | Procedure | — | UNRESOLVED |
| Laparoscopic partial gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endoscopic resection
- description
- The endoscopist will perform endoscopic resection for patients enrolled in this group.
- interventionNames
- Procedure: Endoscopic resection
- type
- OTHER
- label
- Laparoscopic partial gastrectomy
- description
- The endoscopist will perform laparoscopic partial gastrectomy for patients enrolled in this group.
- interventionNames
- Procedure: Laparoscopic partial gastrectomy
Primary outcomes (2)
- measure
- Early operative morbidity rate
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with gastric GISTs in imaging examinations including contrast-enhanced abdominal and pelvic CT, EGD examination and endoscopic ultrasound examination * The maximum diameter of the tumor is \> 2cm and ≤ 5cm * No history of upper abdominal surgery (except for laparoscopic cholecystectomy) * No history of neoadjuvant therapy or targeted therapy * Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1 * Preoperative ASA (American Society of Anesthesiologists) scoring: I-III * Sufficient organ functions * Written informed consent Exclusion Criteria: * Gastric GISTs with completely extra-luminal growth pattern * Metastases found in preopreative examinations * History of simultaneous malignancies or heterochronous malignancies within 5 years * Women during pregnancy or breast-feeding * Severe heart and lung disease, severe renal insufficiency, unable to perform laparoscopic surgery * Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated * Severe mental disease * Severe respiratory disease * Severe hepatic and renal dysfunction * Unstable angina pectoris or history of myocardial infarction within 6 months * History of cerebral infarction or cerebral hemorrhage within 6 months * Patients with other diseases who can be surgically intervened at the same time * Continuous systemic steroid therapy within 1 month (except for topical use) * Patients are participating or have participated in another clinical trial (within 6 months)
References
Publications (18)
- BACKGROUNDKwon JG, Hwang SJ, Hennig GW, Bayguinov Y, McCann C, Chen H, Rossi F, Besmer P, Sanders KM, Ward SM. Changes in the structure and function of ICC networks in ICC hyperplasia and gastrointestinal stromal tumors. Gastroenterology. 2009 Feb;136(2):630-9. doi: 10.1053/j.gastro.2008.10.031. Epub 2008 Nov 1. PMID 19032955
- BACKGROUNDHeinrich MC, Rubin BP, Longley BJ, Fletcher JA. Biology and genetic aspects of gastrointestinal stromal tumors: KIT activation and cytogenetic alterations. Hum Pathol. 2002 May;33(5):484-95. doi: 10.1053/hupa.2002.124124. PMID 12094373
- BACKGROUNDBamboat ZM, Dematteo RP. Updates on the management of gastrointestinal stromal tumors. Surg Oncol Clin N Am. 2012 Apr;21(2):301-16. doi: 10.1016/j.soc.2011.12.004. PMID 22365521
- BACKGROUNDSteigen SE, Eide TJ. Trends in incidence and survival of mesenchymal neoplasm of the digestive tract within a defined population of northern Norway. APMIS. 2006 Mar;114(3):192-200. doi: 10.1111/j.1600-0463.2006.apm_261.x. PMID 16643186
- BACKGROUNDDemetri 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
- BACKGROUNDPucci MJ, Berger AC, Lim PW, Chojnacki KA, Rosato EL, Palazzo F. Laparoscopic approaches to gastric gastrointestinal stromal tumors: an institutional review of 57 cases. Surg Endosc. 2012 Dec;26(12):3509-14. doi: 10.1007/s00464-012-2374-5. Epub 2012 Jun 9. PMID 22684977
- BACKGROUNDOhtani H, Maeda K, Noda E, Nagahara H, Shibutani M, Ohira M, Muguruma K, Tanaka H, Kubo N, Toyokawa T, Sakurai K, Yamashita Y, Yamamoto A, Hirakawa K. Meta-analysis of laparoscopic and open surgery for gastric gastrointestinal stromal tumor. Anticancer Res. 2013 Nov;33(11):5031-41.