CClinicalTrials.gg
RecruitingNCT07615374Updated Sep 14, 2026

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

An interventional study of Laparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation Surgery in Early Gastric Cancer, sponsored by Jilin University. Recruiting at 2 sites in China. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Jilin University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Sex
All
01

Study summary

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

02

Conditions studied

  • Early Gastric Cancer

Browse trials for

Keywords

  • Laparoscopic-endoscopic cooperative surgery
  • Sentinel Lymph Node Navigation
  • Early Gastric Cancer
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Preoperative assessment indicating that the tumor was confined to the mucosa or submucosa, consistent with the diagnosis of early gastric cancer.
  • Patients who required additional surgical intervention following initial endoscopic submucosal dissection (ESD) based on postoperative pathological evaluation.
  • 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

Exclusion Criteria:

  • Preoperative assessment indicating suspected lymph node or distant metastasis.
  • History of complex abdominal surgery rendering laparoscopic treatment infeasible.
  • Participation in another clinical trial within 4 weeks prior to enrollment or currently participating in another trial.
  • History of severe psychiatric disorders.
  • Pregnant or lactating women.
  • Uncontrolled infection prior to surgery.
  • Presence of other malignancies or comorbidities that may significantly affect survival.
  • Any other conditions deemed by the investigators as unsuitable for participation, or refusal by the patient or family to enroll.
  • Cardiopulmonary, hepatic, and renal functions were unsufficient to tolerate the surgery.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureLaparoscopic-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.

05

What researchers measure

Primary outcomes

  1. Incidence of perioperative complications.

    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.

    Time frame: One month after surgery

Secondary outcomes

  1. Number of retrieved lymph nodes.

    The number of lymph nodes retrieved from all resected specimens.

    Time frame: One week after the surgery.

Other outcomes

  1. the number of postoperative hospital stay in days.

    Time from surgery to discharge was recorded in days.

    Time frame: One month after the surgery.

  2. the number of time to first resumption of liquid diet in days

    Time to first resumption of liquid diet was recorded in days.

    Time frame: One month after surgery.

  3. R0 resection rate

    The R0 resection rate was defined as the proportion of patients with histopathologically confirmed complete resection and negative margins among all enrolled patients.

    Time frame: One month after surgery.

  4. the total number of Hospitalization costs in Chinese Yuan (CNY).

    Total hospitalization costs were calculated in Chinese Yuan (CNY).

    Time frame: One month after surgery.

  5. Number of patients requiring further therapy

    Number of patients requiring further therapy (e.g., standard radical gastrectomy or chemotherapy).

    Time frame: Three month after surgery.

  6. the rate of positive cytological examination results of peritoneal lavage fluid.

    Cytological examination of the irrigation fluid from the surgical field was performed postoperatively. A finding of tumor cells was considered positive.

    Time frame: One week after surgery.

06

Study locations

1 of 2 sites recruiting
  • the First Hospital of Jilin University
    Changchun, Jilin 130021, China
    Recruiting
  • the First Hospital of Jilin University
    Ch’ang-ch’un, Jilin 130021, China
    Active, not recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07615374
Lead sponsor
Jilin University
Responsible party
Dong Yang (Principal Investigator, Jilin University) — Principal investigator
First posted
May 29, 2026
Start date
May 12, 2026
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 14, 2026

Study contacts

Quan Wang, Professor
Contact
wquan@jlu.edu.cn
15843073207

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion