Laparoscopic and Endoscopic Collaborative Surgery as Rescue-treatment for Advanced Gastric Cancer (LE-RACUS)

July 21, 2025 updated by: Ioannis Rouvelas, Region Stockholm

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In patients with advanced gastric cancer (AGC), laparoscopic gastrectomy with lymph node dissection in combination with chemotherapy is the recommended treatment for cases with curative intent. However, some patients cannot tolerate such demanding treatment because of comorbidities or advanced age. If gastrectomy or palliative chemotherapy cannot be offered the only remaining alternative is best supportive care.

Patients with AGC that cannot receive definitive surgical or oncological treatment can develop complications such as bleeding from the primary tumor or gastric outlet obstruction. Such complications can be difficult to manage by endoscopic means, and significantly impact the patients' quality of life.

Laparoscopic and endoscopic collaborative surgery (LECS) was reported by Hiki et al in 2008 as a treatment for submucosal tumors. With this method, the endoscopist first performs mucosal incision around the tumor followed by laparoscopic removal of the tumor with endoscopic guidance.

In Japan, the current indication for LECS is gastrointestinal stromal cell tumors with a size of 2-5 cm. LECS has also been described in two case reports as palliative treatment for patients with AGC without being in a state to undergo gastrectomy. To the best of the investigators' knowledge, no prospective trial has studied LECS for this indication. Compared with gastrectomy, LECS is a very safe and much less invasive technique with few severe adverse events. If the tumor could be completely resected with LECS, the risk for bleeding and other tumor-related complications could be diminished which could significantly benefit the patients and improve their quality of life.

In this study, the investigators want to test the safety and feasibility of performing LECS for patients who are unfit for standard treatment with gastrectomy. The patients will be screened for inclusion through a multidisciplinary team meeting. If they meet the inclusion criteria they will be asked to participate in the study on an outpatient meeting with a member of the research team. If the patient agrees to participate and can sign an informed consent, they will be booked for a LECS procedure. After the operation is performed, the patient will meet the researcher again 4-6 weeks later and will be asked to fill in two QoL questionnaires.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional arm
The group that will receive the active treatment
Procedure: Laparoscopic and Endoscopic Collaborative Surgery (LECS)
Minimal invasive surgery in collaboration between endoscopy and laparoscopic surgery, to locally remove the tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe complication
Time Frame: Through study completion, an average of 2 years
Clavien Dindo complication grade >/= III
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any complication
Time Frame: Through study completion, an average of 2 years
Clavien Dindo complication grade II-IV
Through study completion, an average of 2 years
Postoperative bleeding/leakage/postoperative abcess
Time Frame: Through study completion, an average of 2 years
Use of blood transfusion/abcess requiring drainage
Through study completion, an average of 2 years
Operation time/local radicality
Time Frame: Through study completion, an average of 2 years
Time of the surgical procedure/pathology report of radical resection
Through study completion, an average of 2 years
30-day mortality/in-hospital mortality/hospital-stay
Time Frame: Through study completion, an average of 2 years
Mortality within 30 days/mortality during the hospital stay/number of days admitted
Through study completion, an average of 2 years
Health-related quality of life
Time Frame: Through study completion, an average of 2 years
The QLQ-C30/OG25 HQL questionnaire
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Investigators

  • Principal Investigator: Ioannis Rouvelas, MD, PhD, ME Övre buk, Karolinska Universitetssjukhuset

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1298-9641

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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