Tokyo, Aug. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062721) titled 'A Multicenter Study Comparing Appetite-Preserving Gastrectomy and Proximal Gastrectomy for Esophagogastric Junction Cancer' on Aug. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kitasato University

Condition: Condition - Esophagogastric junction cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the safety and functional preservation effects of Appetite-Preserving Gastrectomy (APG) compared with Proximal Gastrectomy (PG) in patients with esophagogastric junction cancer in a multicenter randomized controlled trial. The primary endpoint is the between-group difference in the percentage change in Skeletal Muscle Index (SMI) from baseline to 6 months after surgery. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Appetite-Preserving Gastrectomy (APG) is performed. The gastric fundus containing the ghrelin-producing region is preserved while ensuring an oncologically safe resection margin. Reconstruction consists of esophagojejunostomy and gastrojejunostomy using the preserved stomach. Open, laparoscopic, or robot-assisted approaches are permitted. Interventions/Control_2 - Proximal Gastrectomy (PG) is performed. Reconstruction is performed according to the standard procedure at each participating institution, including esophagogastrostomy, double-tract reconstruction, the Kamikawa procedure, or other reconstruction methods. Open, laparoscopic, or robot-assisted approaches are permitted.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Male or female patients aged 20 to 85 years at enrollment. Patients with esophagogastric junction adenocarcinoma classified as Siewert type II. Patients considered eligible for curative (R0) resection, irrespective of clinical stage. Patients are eligible regardless of whether preoperative chemotherapy has been administered. Patients without severe comorbidities that would preclude safe gastrectomy. Patients without organ failure or severe psychiatric disorders who are considered fit for surgery under general anesthesia. Patients who have received sufficient explanation regarding the purpose and procedures of the study and have provided written informed consent. Key exclusion criteria - Patients with a history of previous gastrectomy. Patients with active synchronous or metachronous malignancy. Patients with distant metastasis detected by preoperative imaging. Patients with severe cardiac, respiratory, hepatic, renal, or other comorbidities that preclude surgery under general anesthesia. Patients with severe active infection. Women who are pregnant or breastfeeding. Patients with psychiatric disorders or cognitive impairment that may interfere with understanding the study or providing appropriate informed consent. Patients who are expected to have difficulty completing scheduled follow-up during the study period. Patients considered unsuitable for participation in the study by the principal investigator or a study investigator. Target Size - 140

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 26 Day Date of IRB - 2026 Year 08 Month 14 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2032 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071814

Disclaimer: Curated by HT Syndication.