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

Primary Purpose

Sentinel Lymph Node, Early Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sentinel basin dissection
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sentinel Lymph Node focused on measuring Sentinel lymph node, Early gastric cancer, Non-curative endoscopic resection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bang Wool EomRecruiting
  • Soonchunhyang University College of MedicineRecruiting
  • Dongnam Institute of Radiological and Medical ScienceRecruiting
  • Gyeongsang National University Changwon Hospital
  • Kyungpook National University Medical Center
  • Chonnam National University Hwasun HospitalRecruiting
  • Gyeongsang National University HospitalRecruiting
  • Samsung Medical Center
  • Ajou University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sentinel basin dissection

Arm Description

Intervention: Sentinel basin dissection

Outcomes

Primary Outcome Measures

detection rate (%)
number of patients whose sentinel nodes are detected / enrolled number of patients *100

Secondary Outcome Measures

False negative rate
number of patients without metastatic lymph node in sentinel basin / number of patients with metastatic lymph node *100

Full Information

First Posted
April 10, 2017
Last Updated
March 23, 2023
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03123042
Brief Title
Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic Resection
Acronym
SENORITA2
Official Title
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Patients After Non-curative Endoscopic Resection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sentinel Lymph Node, Early Gastric Cancer
Keywords
Sentinel lymph node, Early gastric cancer, Non-curative endoscopic resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
247 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sentinel basin dissection
Arm Type
Experimental
Arm Description
Intervention: Sentinel basin dissection
Intervention Type
Procedure
Intervention Name(s)
Sentinel basin dissection
Intervention Description
Sentinel basin detection using endoscopic detector (Tc99m plus indocyanine green) injection and laparoscopic sentinel basin dissection. Then conventional gastrectomy
Primary Outcome Measure Information:
Title
detection rate (%)
Description
number of patients whose sentinel nodes are detected / enrolled number of patients *100
Time Frame
15 days after operation
Secondary Outcome Measure Information:
Title
False negative rate
Description
number of patients without metastatic lymph node in sentinel basin / number of patients with metastatic lymph node *100
Time Frame
15 days after operation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bang Wool Eom, MD, PhD
Phone
82-31-920-1689
Email
kneeling79@ncc.re.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Keun Won Ryu, MD.PhD
Phone
82-31-920-1628
Email
docryu@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bang Wool Eom, MD, PhD
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bang Wool Eom
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bang Wool Eom, MD,PhD
Phone
82-31-920-1689
Email
kneeling79@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Keun Won Ryu, MD,PhD
Phone
8-31-920-1628
Email
docryu@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Bang Wool Eom, MD,PhD
First Name & Middle Initial & Last Name & Degree
Keun Won Ryu, MD,PhD
First Name & Middle Initial & Last Name & Degree
Young-Woo Kim, MD,PhD
First Name & Middle Initial & Last Name & Degree
Hong Man Yoon, MD,MS
First Name & Middle Initial & Last Name & Degree
Il Ju Choi, MD,PhD
First Name & Middle Initial & Last Name & Degree
Chan Gyoo Kim, MD,PhD
First Name & Middle Initial & Last Name & Degree
Soo-Jeong Cho, MD,PhD
First Name & Middle Initial & Last Name & Degree
Young-Il Kim, MD,MS
First Name & Middle Initial & Last Name & Degree
Myeong-Cherl Kook, MD,PhD
First Name & Middle Initial & Last Name & Degree
Soo Jin Kim, MD,PhD
First Name & Middle Initial & Last Name & Degree
Ji Yoon Rho, MD,PhD
First Name & Middle Initial & Last Name & Degree
Seok Ki Kim, MD,PhD
Facility Name
Soonchunhyang University College of Medicine
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In Cho, MD
Email
join34@hanmail.net
First Name & Middle Initial & Last Name & Degree
Gyu Seok Cho
First Name & Middle Initial & Last Name & Degree
In Cho
Facility Name
Dongnam Institute of Radiological and Medical Science
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Seok Min, MD, PhD
Email
mdoogy@hanmail.net
First Name & Middle Initial & Last Name & Degree
Jae-Seok Min, MD, PhD
Facility Name
Gyeongsang National University Changwon Hospital
City
Changwon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Ho Jeong, MD, PhD
Email
jshgnuh@naver.com
First Name & Middle Initial & Last Name & Degree
Sang-Ho Jeong, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tae-Han Kim, MD
Facility Name
Kyungpook National University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Yeon Park, MD, MS
Email
jybark990118@naver.com
First Name & Middle Initial & Last Name & Degree
Ji Yeon Park, MD, MS
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Kyu Park, MD, PhD
Phone
82-61-379-7644
Email
parkyk@jnu.ac.kr
First Name & Middle Initial & Last Name & Degree
Young Kyu Park, MD,PhD
First Name & Middle Initial & Last Name & Degree
Oh Jeong, MD,PhD
First Name & Middle Initial & Last Name & Degree
Mi-Ran Jung, MD,PhD
Facility Name
Gyeongsang National University Hospital
City
Jinju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji-Ho Park, MD
Email
goodgsdr@gmail.com
First Name & Middle Initial & Last Name & Degree
Ji-Ho Park, MD
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ho Lee, MD,PhD
Email
gsjunholee@gmail.com
First Name & Middle Initial & Last Name & Degree
Jun Ho Lee, MD,PhD
First Name & Middle Initial & Last Name & Degree
Ji Young An, MD,PhD
Facility Name
Ajou University School of Medicine
City
Suwon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoon Hur, MD, PhD
Email
hhcmc75@naver.com
First Name & Middle Initial & Last Name & Degree
Hoon Hur, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31245160
Citation
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.
Results Reference
derived

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

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