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

Sentinel Lymph Node Clinical Trial

— SENORITA2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03123042
• Other study ID #: 1710162
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: National Cancer Center, Korea
• Contact: Bang Wool Eom, MD, PhD
• Phone: 82-31-920-1689
• Email: kneeling79[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 247
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Sentinel Lymph Node
• Stomach Neoplasms

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection rate (%)	number of patients whose sentinel nodes are detected / enrolled number of patients *100	15 days after operation
Secondary	False negative rate	number of patients without metastatic lymph node in sentinel basin / number of patients with metastatic lymph node *100	15 days after operation