NCT05205343

Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.

Detailed description

Primary Objective: Delineate the short-term appetite of patients who undergo minimally-invasive proximal gastrectomy (MIPG) and compare them with those of patients with gastric and gastroesophageal adenocarcinoma who undergo total gastrectomy (MITG). We hypothesize that MIPG is associated with better postoperative appetite levels compared to MITG, which would result in improved nutritional status and maintained body weight after surgery. Secondary Objective: \- Assess patient-reported outcomes (PROs) and nutrition measures. We will use the MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI) questionnaire with additional three experimental question items ("PRO questionnaire") to collect preoperative and postoperative patient-reported outcomes (PROs) of QoL and check fasting ghrelin levels to correlate them with reported appetite levels. We will also retrospectively investigate factors associated with improved QoL after surgery, safety of MIPG and MITG, and oncological outcomes after MIPG and MITG.

Conditions

• Gastrostomy
• Gastric
• GastroEsophageal Cancer

Interventions

Type	Name	Description
OTHER	Standard of Care	complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery
OTHER	Control Group	complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery

Timeline

• Start date: 2022-05-11
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2022-01-25
• Last updated: 2026-02-04

Locations

4 sites across 3 countries: United States, Japan, South Korea