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

NCT03123042 | Completed DMC

• 1 other identifier: 1710162
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Sentinel Lymph Node; Early Gastric Cancer

Keywords

Sentinel lymph node; Early gastric cancer; Non-curative endoscopic resection

Outcome Measures

Primary Outcomes (1)

• detection rate (%)

  number of patients whose sentinel nodes are detected / enrolled number of patients \*100

  15 days after operation

Secondary Outcomes (1)

• False negative rate

  15 days after operation

Study Arms (1)

Sentinel basin dissection

EXPERIMENTAL

Intervention: Sentinel basin dissection

Procedure: Sentinel basin dissection

Interventions

Sentinel basin dissection PROCEDURE

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

Sentinel basin dissection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (9)

Bang Wool Eom

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Soonchunhyang University College of Medicine

Bucheon-si, South Korea

Location

Dongnam Institute of Radiological and Medical Science

Busan, South Korea

Location

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Location

Kyungpook National University Medical Center

Daegu, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Ajou University School of Medicine

Suwon, South Korea

Location

Related Publications (1)

• Eom BW, Yoon HM, Min JS, Cho I, Park JH, Jung MR, Hur H, Kim YW, Park YK, Nam BH, Ryu KW; Sentinel Node Oriented Tailored Approach (SENORITA) Study Group. Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol. J Gastric Cancer. 2019 Jun;19(2):157-164. doi: 10.5230/jgc.2019.19.e12. Epub 2019 Apr 15.

  PMID: 31245160 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Bang Wool Eom, MD, PhD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff surgeon

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 21, 2017
• Study Start: March 20, 2017
• Primary Completion: November 21, 2024
• Study Completion: December 31, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9)