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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after surgery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
(MDASI-GI) MD Anderson Symptom Inventory Questionnaire

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
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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,296 Total Patients Enrolled
Naruhiko Ikoma, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Minimally Invasive Proximal Gastrectomy Clinical Trial Eligibility Overview. Trial Name: NCT05205343 — N/A
Gastroesophageal Cancer Research Study Groups: Standard of Care, Control group
Gastroesophageal Cancer Clinical Trial 2023: Minimally Invasive Proximal Gastrectomy Highlights & Side Effects. Trial Name: NCT05205343 — N/A
Minimally Invasive Proximal Gastrectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05205343 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate sum of participants enrolled in this experiment?

"Correct. According to information listed on clinicaltrials.gov, this medical experiment was first posted on May 11th 2022 and is currently recruiting patients. In total, 20 participants will be sought from a single clinic site."

Answered by AI

Are enrollments for this clinical trial in progress?

"Affirmative. The clinicaltrials.gov website confirms that this medical trial is actively recruiting patients, with the original posting occuring on May 11th 2022 and the most recent amendment occurring October 20th 2022. In total, it requires 20 people to be enrolled at a single site for participation in the study."

Answered by AI
~1 spots leftby May 2024