NCT07615374

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
43mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2029

Study Start

First participant enrolled

May 12, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

May 22, 2026

Last Update Submit

May 31, 2026

Conditions

Early Gastric Cancer

Keywords

Laparoscopic-endoscopic cooperative surgerySentinel Lymph Node NavigationEarly Gastric Cancer

Outcome Measures

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.

    One month after surgery

Secondary Outcomes (1)

  • Number of retrieved lymph nodes.

    One week after the surgery.

Other Outcomes (6)

  • the number of postoperative hospital stay in days.

    One month after the surgery.

  • the number of time to first resumption of liquid diet in days

    One month after surgery.

  • R0 resection rate

    One month after surgery.

  • +3 more other outcomes

Study Arms (1)

Sentinel Lymph Node Navigation Surgery

EXPERIMENTAL

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

Laparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation SurgeryPROCEDURE

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.

Sentinel Lymph Node Navigation Surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, 130021, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

May 12, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

June 3, 2026

Record last verified: 2026-05

Locations

CN(1)