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NCT Number: NCT06105515

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 14186, Sweden

Location status: Recruiting

Location contact

Henrik Maltzman, Dr

CONTACT

[email protected]

Ioannis Rouvelas, Dr

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic and Endoscopic Collaborative Surgery (LECS)

Procedure

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

Primary outcomes

  1. Severe complication

    Time frame: Through study completion, an average of 2 years

    Clavien Dindo complication grade >/= III

Secondary outcomes

  1. Any complication

    Time frame: Through study completion, an average of 2 years

    Clavien Dindo complication grade II-IV

  2. Postoperative bleeding/leakage/postoperative abcess

    Time frame: Through study completion, an average of 2 years

    Use of blood transfusion/abcess requiring drainage

  3. Operation time/local radicality

    Time frame: Through study completion, an average of 2 years

    Time of the surgical procedure/pathology report of radical resection

  4. 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

  5. Health-related quality of life

    Time frame: Through study completion, an average of 2 years

    The QLQ-C30/OG25 HQL questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Henrik Maltzman, MD

CONTACT

[email protected]

+46706334445

Ioannis Rouvelas, MD, PhD

CONTACT

[email protected]

+46707976814

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Official study title

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

Acronym: LE-RACUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 27, 2023
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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