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

Last updated: March 27, 2025
Sponsor: National Cancer Center, Korea
Overall Status: Completed

Phase

N/A

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

Sentinel basin dissection

Clinical Study ID

NCT03123042
1710162
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • No limitation for age if the patient is available for gastrectomy

  • Patient who underwent endoscopic submucosal dissection and the tumor was defined asout of indication.

The expanded criteria for endoscopic resection are as follows

  • criterion I: intramucosal tumor without ulcerative findings and of differentiatedtype with size > 2 cm

  • criterion II: intramucosal tumor with ulcerative findings and of differentiated typewith size ≤ 3 cm

  • criterion III: intramucosal tumor without ulcerative findings and ofundifferentiated type with size < 2 cm

  • criterion IV, submucosal invasion < 500 mm and of differentiated type with size ≤ 3cm)

  • Eastern Cooperative Oncology Group (ECOG) performance scale 0 or 1

Exclusion

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 radiationtherapy on upper abdomen, or hypersensitivity to any medicine

Study Design

Total Participants: 243
Treatment Group(s): 1
Primary Treatment: Sentinel basin dissection
Phase:
Study Start date:
March 20, 2017
Estimated Completion Date:
December 31, 2024

Study 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

Connect with a study center

  • Bang Wool Eom

    Goyang, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • Soonchunhyang University College of Medicine

    Bucheon,
    Korea, Republic of

    Site Not Available

  • Dongnam Institute of Radiological and Medical Science

    Busan,
    Korea, Republic of

    Site Not Available

  • Gyeongsang National University Changwon Hospital

    Changwon,
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun,
    Korea, Republic of

    Site Not Available

  • Gyeongsang National University Hospital

    Jinju,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University School of Medicine

    Suwon,
    Korea, Republic of

    Site Not Available

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