Laparoscopic-endoscopic Surgery Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer

May 22, 2026 updated by: Dong Yang, Jilin University

A Prospective Registry Study of Laparoscopic-endoscopic Cooperative Surgery Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer

This study is to evaluate the safety and efficacy of dual-endoscope assisted sentinel lymph node navigation surgery for early gastric cancer (EGC).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

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 Locations

  • China
    • Jilin
      • Ch’ang-ch’un, Jilin, China, 130021
        • The First Hospital of Jilin University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Preoperative assessment indicating that the tumor was confined to the mucosa or submucosa, consistent with the diagnosis of early gastric cancer.

    2. Patients who required additional surgical intervention following initial endoscopic submucosal dissection (ESD) based on postoperative pathological evaluation.

    3. Patients and their families fully understood the procedure, requested dual-endoscope assisted sentinel lymph node navigation surgery, agreed to participate in this clinical study, and signed the informed consent form.

Exclusion Criteria:

  • 1. Preoperative assessment indicating suspected lymph node or distant metastasis.

    2. History of complex abdominal surgery rendering laparoscopic treatment infeasible.

    3. Participation in another clinical trial within 4 weeks prior to enrollment or currently participating in another trial.

    4. History of severe psychiatric disorders. 5. Pregnant or lactating women. 6. Uncontrolled infection prior to surgery. 7. Presence of other malignancies or comorbidities that may significantly affect survival.

    8. Any other conditions deemed by the investigators as unsuitable for participation, or refusal by the patient or family to enroll.

    9. Cardiopulmonary, hepatic, and renal functions were unsufficient to tolerate the surgery.

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: Sentinel Lymph Node Navigation Surgery
Laparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer
Procedure: Laparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation Surgery
After preoperative assessment and confirmation of eligibility, patients received general anesthesia with endotracheal intubation. Indocyanine green (ICG) was injected submucosally around the lesion in four quadrants to trace the sentinel lymph node (SLN) basin. Laparoscopic marking of the SLN basin was performed. Endoscopy assisted laparoscopy in marking the primary lesion border (ensuring a margin of >0.5 cm). Laparoscopic sentinel lymph node dissection was performed, followed by endoscopic/laparoscopic full-thickness resection of the lesion. Gastric wall defects were closed laparoscopically. SLNs were harvested and sent for intraoperative frozen section pathology. If positive, a standard radical gastrectomy was performed; if negative, an abdominal drainage tube was placed to complete the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of perioperative complications.
Time Frame: One month after surgery
Postoperative complications comprised hemorrhage, obstruction, gastrointestinal motility disorders, and fistulas. The overall complication rate was calculated as the number of patients with complications divided by the total number of patients in the cohort.
One month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of retrieved lymph nodes.
Time Frame: One week after the surgery.
The number of lymph nodes retrieved from all resected specimens.
One week after the surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hospital stay (days).
Time Frame: One month after the surgery.
Time from surgery to discharge was recorded in days.
One month after the surgery.
Time to first resumption of liquid diet
Time Frame: One month after surgery.
Time to first resumption of liquid diet was recorded in days.
One month after surgery.
R0 resection rate
Time Frame: One month after surgery.
The R0 resection rate was defined as the proportion of patients with histopathologically confirmed complete resection and negative margins among all enrolled patients.
One month after surgery.
Hospitalization costs.
Time Frame: One month after surgery.
Total hospitalization costs were calculated in Chinese Yuan (CNY).
One month after surgery.
Number of patients requiring further therapy
Time Frame: Three month after surgery.
Number of patients requiring further therapy (e.g., standard radical gastrectomy or chemotherapy).
Three month after surgery.
Cytological examination results of peritoneal lavage fluid.
Time Frame: One week after surgery.
Cytological examination of the irrigation fluid from the surgical field was performed postoperatively. A finding of tumor cells was considered positive.
One week after surgery.

Collaborators and Investigators

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

Sponsor

Jilin University

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)

May 12, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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