Enhanced vs. Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial

Launched by FUDAN UNIVERSITY · Jun 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the differences between enhanced follow-up care and standard follow-up care for patients who have had surgery for advanced gastric cancer. The main goal is to see if enhanced follow-up can help reduce symptoms and improve the quality of life for these patients. It will also look at whether this type of follow-up affects how long patients live after their surgery, specifically at the 3 and 5-year marks.

To participate in this trial, you should be between 18 and 72 years old, have undergone a total gastrectomy (a surgery that removes the stomach), and have been diagnosed with advanced stomach cancer. You will be randomly placed in either the enhanced follow-up group, where you’ll receive thorough check-ups every three weeks, or the standard follow-up group, which involves routine check-ups as needed. Throughout the study, researchers will assess your quality of life and overall health. This trial has not started recruiting participants yet and will include 158 patients over a span of five years.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 18 to 72 years at the time of informed consent.
• • Underwent radical total gastrectomy.
• • Postoperative pathology confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction.
• • Estimated survival time ≥3 months.
• • Good cognitive and reading abilities, capable of completing questionnaires.
• • Willing and able to provide written informed consent for the study.
• Exclusion Criteria:
• • Participation in another clinical trial within 4 weeks prior to enrollment.
• • Patients with other malignancies.
• • Clinically significant cardiovascular disease, such as heart failure (NYHA III-IV), uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, or hypertension.
• • Neurological or psychiatric disorders affecting cognitive function, including central nervous system metastasis.
• • Active infectious diseases, such as active hepatitis or tuberculosis.
• • Uncontrolled systemic diseases, such as poorly controlled diabetes.
• • Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest X-ray/CT.
• • Pregnant or breastfeeding.