Non-exposure Simple Suturing EFTR (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)
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|ClinicalTrials.gov Identifier: NCT03837301|
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during operation. An endoscopic full-thickness resection method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing endoscopic full-thickness resection, NESS-EFTR) was recently developed.
This is the phase2 study to identify the efficacy of NESS-EFTR with sentinel node navigation in early gastric cancer patients.
|Condition or disease||Intervention/treatment||Phase|
|Early Gastric Cancer||Procedure: NESS-EFTR with sentinel lymph node navigation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)|
|Actual Study Start Date :||September 12, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation (basin dissection)
Procedure: NESS-EFTR with sentinel lymph node navigation
Non-exposure Simple Suturing Endoscopic Full-Thickness Resection with sentinel lymph node navigation (basin dissection) for early gastric cancer patients
- complete resection rate (%) of tumor [ Time Frame: 2 weeks ]the definition of complete resection is 'Tumor exist in single resected piece (en bloc resection) with clear resection margin'.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837301
|Contact: Chan G Kim, M.D.||+email@example.com|
|Korea, Republic of|
|National Cancer Center||Recruiting|
|Goyang, Korea, Republic of, 10408|
|Contact: Chan G Kim, M.D.|
|Principal Investigator:||Chan G Kim, M.D.||National Cancer Center|