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Minimally Invasive Gastrectomies for Gastroesophageal Cancer

N/A

Recruiting

Led By Naruhiko Ikoma, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age ≥ 18

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial compared the symptoms of patients with a MIPG to the symptoms of patients with a MITG.

Who is the study for?

This trial is for adults with non-metastatic gastric or gastroesophageal junction cancers who are set to undergo minimally invasive surgery. Participants must speak and read English, Spanish, Korean, or Japanese depending on the study location. Pregnant individuals, those unable to follow the study procedures, with malabsorption syndromes or compromised gastrointestinal integrity, or high narcotic dependence cannot join.

What is being tested?

The study aims to compare symptoms after two types of surgeries for upper stomach cancer: Minimally Invasive Proximal Gastrectomy (MIPG) and Minimally Invasive Total Gastrectomy (MITG). Patients will be observed post-surgery to assess their recovery and symptom management.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects from these surgical interventions may include pain at the incision site, fatigue, difficulty eating or digesting food properly initially after surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed diagnosis of early-stage stomach cancer and am scheduled for surgery with the intent to cure.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take more than 5 mg of morphine or its equivalent daily due to narcotic dependence.

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I have a condition that affects how my body absorbs nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

(MDASI-GI) MD Anderson Symptom Inventory Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of CareExperimental Treatment1 Intervention

questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery. The questionnaire will ask about your health, appetite, and quality of life. It should take about 3-5 minutes to complete.

Group II: Control groupExperimental Treatment1 Intervention

0 / 4Eligibility criteria met