PPIO-007 Correlation Analysis of Type II Diabetes Mellitus on Short-term and Long-term Outcomes o… (NCT06333665) | Clinical Trial Compass
CompletedNot Applicable
PPIO-007 Correlation Analysis of Type II Diabetes Mellitus on Short-term and Long-term Outcomes of Patients With Esophageal Squamous Cell Cancer Undergoing Minimally Invasive Esophagectomy
China605 participantsStarted 2024-02-20
Plain-language summary
To date, there is controversy as to whether type II diabetes mellitus is associated with adverse short- and long-term outcomes in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy. At the same time, to the best of our knowledge, the impact of metformin use and glycemic control on short- and long-term outcomes in this patient population is also controversial. Therefore, this study aims to test the hypothesis that diabetes mellitus is associated with reduced survival in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy and that treatment with metformin and/or good glycemic control (HbA1c\<7.0%) is associated with improved survival.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with a clear pathologic diagnosis of esophageal squamous cell carcinoma;
. Received minimally invasive McKeown procedure;
. Patients with R0 resection (R0: radical resection).
Exclusion criteria
. Concomitant history of other primary cancers or other cancers;
. Distant metastases before surgery;
. Serious comorbidities of other systems before surgery;
. Patients diagnosed with T2DM during follow-up;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall survival
Timeframe: About five years postoperatively
2
Disease-free survival
Timeframe: About five years postoperatively
Trial details
NCT IDNCT06333665
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University