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

GastroEsophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205343
• Other study ID #: 2021-0914
• Secondary ID: NCI-2022-00267
• Status: Recruiting
• Start date: May 11, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: October 2023
• Source: M.D. Anderson Cancer Center
• Contact: Naruhiko Ikoma, MD
• Phone: (832) 729-2675
• Email: nikoma[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Primary Objectives:

• 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 Objectives:

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to speak and read English or Spanish (for patients enrolled at MD Anderson and Mayo Clinic), English or Korean (for patients enrolled at Yonsei), and English or Japanese (for patients enrolled at Keio)

2. Patients with a biopsy-confirmed diagnosis of non-metastatic gastric or GEJ adenocarcinoma, who are scheduled to undergo MIPG or MITG for curative-intention

3. Age = 18

Exclusion Criteria:

1. Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract

2. Patients with known narcotic dependence, with average daily dose > 5 mg oral morphine equivalent

3. Subjects deemed unable to comply with study and/or follow-up procedures, at investigators' discretion

4. Patients who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG)

Related Conditions & MeSH terms

• GastroEsophageal Cancer
• Gastrostomy

Intervention

Other:
• Standard of Care
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery
• Control Group
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery

Locations

Country	Name	City	State
Japan	Keio University School of Medicine	Tokyo
Korea, Democratic People's Republic of	Yonsei University College of Medicine	Soeul
United States	M D Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Countries where clinical trial is conducted

United States,  Japan,  Korea, Democratic People's Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(MDASI-GI) MD Anderson Symptom Inventory Questionnaire	Appetite level (reported on a 0-10 scale, in Q8 of MDASI-GI) scale 0-not present-10 as bad as you can image	3 months after surgery

External Links

•   M D Anderson Cancer Center