Clinical trial NCT03123042: Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic Resection
Official title: Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Patients After Non-curative Endoscopic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sentinel Lymph Node
Early Gastric Cancer
Keywords: Sentinel lymph node
Early gastric cancer
Non-curative endoscopic resection
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2017-04-21
Enrollment: 243
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

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

Primary outcomes:
measure: detection rate (%)
timeFrame: 15 days after operation
Secondary outcomes:
measure: False negative rate
timeFrame: 15 days after operation
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Bang Wool Eom
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University College of Medicine
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiological and Medical Science
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
affiliation: National Cancer Center, Korea
name: Bang Wool Eom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.