Gastric Cancer Clinical Trial
— LE-RACUSOfficial title:
Laparoscopic and Endoscopic Collaborative Surgery as Rescue-treatment for Advanced Gastric Cancer in Patients Unfit for Surgery - the LE-RACUS Pilot Clinical Study
The standard treatment for advanced gastric cancer without metastases is gastrectomy, where the whole stomach or a large proportion is removed surgically together with regional lymph nodes. Some patients cannot tolerate this invasive procedure because of old age or comorbidities. A tumor left in place can cause local symptoms such as bleeding or outlet obstruction. In this study, the investigators want to test the safety and feasibility of Laparoscopic and Endoscopic Collaborative Surgery (LECS) as a less invasive treatment option to locally remove gastric tumors without requiring extensive surgery in these frail patients. LECS is a minimally invasive surgical technique where the tumor margin is first marked from the inside with a gastroscope, followed by surgical removal of the lesion under endoscopic guidance.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | February 1, 2027 |
Est. primary completion date | December 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - pT2-T4aN0M0 gastric carcinoma - Borrmann type 1-2 < 5 cm or Borrmann type 3 < 2 cm - Patient assessment by the multidisciplinary tumor board as not fit for gastrectomy - Signed informed consent Exclusion Criteria: - Borrman type 4 - Location in the cardia |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Region Stockholm |
Sweden,
de Brito SO, Libanio D, Pinto CMM, de Araujo Teixeira JPPO, de Araujo Teixeira JPM. Efficacy and Safety of Laparoscopic Endoscopic Cooperative Surgery in Upper Gastrointestinal Lesions: A Systematic Review and Meta-Analysis. GE Port J Gastroenterol. 2022 Nov 7;30(1):4-19. doi: 10.1159/000526644. eCollection 2023 Jan. — View Citation
Hiki N, Yamamoto Y, Fukunaga T, Yamaguchi T, Nunobe S, Tokunaga M, Miki A, Ohyama S, Seto Y. Laparoscopic and endoscopic cooperative surgery for gastrointestinal stromal tumor dissection. Surg Endosc. 2008 Jul;22(7):1729-35. doi: 10.1007/s00464-007-9696-8. Epub 2007 Dec 12. — View Citation
Takechi H, Fujikuni N, Takemoto Y, Tanabe K, Amano H, Noriyuki T, Nakahara M. Palliative surgery for advanced gastric cancer: Partial gastrectomy using the inverted laparoscopic and endoscopic cooperative surgery method. Int J Surg Case Rep. 2018;50:42-45. doi: 10.1016/j.ijscr.2018.06.042. Epub 2018 Jul 21. — View Citation
Washio M, Hiki N, Hosoda K, Niihara M, Chuman M, Sakuraya M, Wada T, Harada H, Sato T, Tanaka K, Naitoh T, Kumamoto Y, Sangai T, Tanabe S, Yamashita K. Laparoscopic and endoscopic cooperative surgery for advanced gastric cancer as palliative surgery in elderly patients: a case report. Surg Case Rep. 2021 Nov 15;7(1):241. doi: 10.1186/s40792-021-01325-1. — View Citation
Zhou Y, Yu F, Wu L, Ye F, Zhang L, Li Y. Survival after Gastrectomy in Node-Negative Gastric Cancer: A Review and Meta-Analysis of Prognostic Factors. Med Sci Monit. 2015 Jul 2;21:1911-9. doi: 10.12659/MSM.893856. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severe complication | Clavien Dindo complication grade >/= III | Through study completion, an average of 2 years | |
Secondary | Any complication | Clavien Dindo complication grade II-IV | Through study completion, an average of 2 years | |
Secondary | Postoperative bleeding/leakage/postoperative abcess | Use of blood transfusion/abcess requiring drainage | Through study completion, an average of 2 years | |
Secondary | Operation time/local radicality | Time of the surgical procedure/pathology report of radical resection | Through study completion, an average of 2 years | |
Secondary | 30-day mortality/in-hospital mortality/hospital-stay | Mortality within 30 days/mortality during the hospital stay/number of days admitted | Through study completion, an average of 2 years | |
Secondary | Health-related quality of life | The QLQ-C30/OG25 HQL questionnaire | Through study completion, an average of 2 years |
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