Laparoscopic and Endoscopic Collaborative Surgery as Rescue-treatment for Advanced Gastric Cancer in Patients Unfit for Surgery - the LE-RACUS Pilot Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Ioannis Rouvelas, MD, PhD
ioannis.rouvals@regionstockholm.se
+46707976814
Backup
Henrik Maltzman, MD
henrik.maltzman@regionstockholm.se
+46706334445
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 20
Treatments
Experimental: Interventional arm
The group that will receive the active treatment
Related Therapeutic Areas
Sponsors
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov