Laparoscopic and Endoscopic Collaborative Surgery as Rescue-treatment for Advanced Gastric Cancer

NCT06105515 | Recruiting

• 1 other identifier: U1111-1298-9641
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

Laparoscopic and endoscopic collaborative surgery; Gastric cancer

Outcome Measures

Primary Outcomes (1)

• Severe complication

  Clavien Dindo complication grade \>/= III

  Through study completion, an average of 2 years

Secondary Outcomes (5)

• Any complication

  Through study completion, an average of 2 years

• Postoperative bleeding/leakage/postoperative abcess

  Through study completion, an average of 2 years

• Operation time/local radicality

  Through study completion, an average of 2 years

• 30-day mortality/in-hospital mortality/hospital-stay

  Through study completion, an average of 2 years

• Health-related quality of life

  Through study completion, an average of 2 years

Study Arms (1)

Interventional arm

EXPERIMENTAL

The group that will receive the active treatment

Procedure: Laparoscopic and Endoscopic Collaborative Surgery (LECS)

Interventions

Laparoscopic and Endoscopic Collaborative Surgery (LECS) PROCEDURE

Minimal invasive surgery in collaboration between endoscopy and laparoscopic surgery, to locally remove the tumor

Interventional arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Borrman type 4
• Location in the cardia

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

RECRUITING

Related Publications (6)

• 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.

  PMID: 26134762 BACKGROUND

• 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.

  PMID: 18074180 BACKGROUND

• 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.

  PMID: 30077165 BACKGROUND

• 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.

  PMID: 34779942 BACKGROUND

• 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.

  PMID: 36743984 BACKGROUND

• Maltzman H, Omae M, Klevebro F, Baldaque-Silva F, Rouvelas I. Laparoscopic and Endoscopic cooperative surgery as Rescue-treatment for Advanced gastric Cancer in patients Unfit for Surgery (LE-RACUS): protocol for a feasibility study. Pilot Feasibility Stud. 2025 Jan 3;11(1):1. doi: 10.1186/s40814-024-01584-3.

  PMID: 39754254 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ioannis Rouvelas, MD, PhD

  ME Övre buk, Karolinska Universitetssjukhuset

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioannis Rouvelas, MD, PhD

CONTACT

+46707976814; ioannis.rouvals@regionstockholm.se

Henrik Maltzman, MD

CONTACT

+46706334445; henrik.maltzman@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: April 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)