Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic Resection (SENORITA2)

March 27, 2025 updated by: Bang Wool Eom, National Cancer Center, Korea

Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Patients After Non-curative Endoscopic Resection

Purpose: To prove the feasibility of sentinel node navigation surgery (SNNS) in early gastric cancer patients with the risk of lymph node metastasis after endoscopic resection and preparation of multicenter phase 3 trial of stomach preserving surgery in these patients.

Contents: The number of enrollment is 247 patients. The patients underwent endoscopic resection for early gastric cancer, and the tumor was defined to be out of indication for endoscopic resection pathologically. So, additional gastrectomy is recommended for them.

The investigators will enroll patients who agree this study. After general anesthesia, Tc99m-Phytate with indocyanine green will be injected with endoscopy. Then sentinel basin will be detected using gamma probe and laparoscopic basin dissection will be done. Sentinel lymph node will be identify in back table dissection, and patients will undergo conventional gastrectomy. Detection rate and false negative rate will be evaluated by pathological review.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sentinel basin dissection method

  1. endoscopic tracer injection after general anesthesia
  2. Tracer : Tc99m-phytate 3cc and indocyanine green 3cc mix --> Injection of the probe (1cc/site, 4 sites) around endoscopic submucosal dissection ulcer scar
  3. Sentinel basin identification with laparoscopic probe
  4. Dissection of the sentinel basin
  5. Sentinel node dissection at back table
  6. Conventional laparoscopic gastrectomy

Study Type

Interventional

Enrollment (Actual)

243

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

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Soonchunhyang University College of Medicine
      • Busan, Korea, Republic of
        • Dongnam Institute of Radiological and Medical Science
      • Changwon, Korea, Republic of
        • Gyeongsang National University Changwon Hospital
      • Daegu, Korea, Republic of
        • Kyungpook National University Medical Center
      • Hwasun, Korea, Republic of
        • Chonnam National University Hwasun Hospital
      • Jinju, Korea, Republic of
        • Gyeongsang National University Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Suwon, Korea, Republic of
        • Ajou University School of Medicine
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 10408
        • Bang Wool Eom

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:

  • No limitation for age if the patient is available for gastrectomy
  • Patient who underwent endoscopic submucosal dissection and the tumor was defined as out of indication.

The expanded criteria for endoscopic resection are as follows

  • criterion I: intramucosal tumor without ulcerative findings and of differentiated type with size > 2 cm
  • criterion II: intramucosal tumor with ulcerative findings and of differentiated type with size ≤ 3 cm
  • criterion III: intramucosal tumor without ulcerative findings and of undifferentiated type with size < 2 cm
  • criterion IV, submucosal invasion < 500 mm and of differentiated type with size ≤ 3 cm)
  • Eastern Cooperative Oncology Group (ECOG) performance scale 0 or 1

Exclusion Criteria:

  • Inoperative due to severe cardiovascular or pulmonary disease
  • Pregnant
  • Patients who had previous gastric surgery
  • Patients who had previous upper abdomen surgery except cholecystectomy, or radiation therapy on upper abdomen, or hypersensitivity to any medicine

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 basin dissection
Intervention: Sentinel basin dissection
Procedure: Sentinel basin dissection
Sentinel basin detection using endoscopic detector (Tc99m plus indocyanine green) injection and laparoscopic sentinel basin dissection. Then conventional gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection rate (%)
Time Frame: 15 days after operation
number of patients whose sentinel nodes are detected / enrolled number of patients *100
15 days after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
False negative rate
Time Frame: 15 days after operation
number of patients without metastatic lymph node in sentinel basin / number of patients with metastatic lymph node *100
15 days after operation

Collaborators and Investigators

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

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Bang Wool Eom, MD, PhD, National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 20, 2017

Primary Completion (Actual)

November 21, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1710162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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