Validation study of local resection with left gastric artery lymphatic basin dissection for upper third early gastric cancer.

JRCT ID: jRCT1030220280

Registered date:19/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 19/08/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Function-sparing gastrectomy (local resection with left gastric artery lymphatic basin dissection) is performed for patients who meet the eligibility criteria. If intraoperative frozen biopsy reveals positive lymph node metastasis (LNM), standard gastrectomy is performed. If postoperative pathology reveals positive resection margins or lymph node metastasis, a two-stage standard gastrectomy is performed.

Outcome(s)

• Primary Outcome: Surgical morbidity: with in 30 days after surgery, Glade 2 or more by the Clavien-Dindo classification

Secondary Outcome

Efficacy: number or retrieved lymph nodes (LNs), number of pathologically positive LNs, surgical margin status of the stomach, depth of tumor invasion, recurrence, recurrence pattern, 3-years relapse free survival ratio, 3-years survival status, posr operative body weight change, questioneer of quality life after gastrectomy
Safety: operation time, intraoperative blood loss, intraoperative accident, postoperative hospital stay

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 1) 18 years old or older, 2) Histologically proven gastric adenocarcinoma 3) cT1N0M0, 4) Tumor located in upper third of the stomach, 5) Distant from cardia more than 1cm, 6) Tumor size 4cm or lesser, 7) single cancer, 8) Written informed consent
• Exclude criteria: 1) meet the application criteria of endoscopic submucosal dissection (ESD), 2) Tumor located in esophago-gastric junction, 3) remnant stomach cancer, 4) emergency operation, 5) histoly of radiation therapy

Related Information

• Primary Sponsor: Akashi Yoshimasa
• Source(s) of Monetary Support: Department of gastrointestinal and hepatobilliary pancreatic surgery, University of Tsukuba