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

NCT06333665 | Completed

• 1 other identifier: Wei G
• Study Type: observational
• Target: 605
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma; Surgery

Keywords

Esophageal Squamous Cell Carcinoma; diabetes mellitus; surgery; postoperative complications; survival outcomes

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Overall survival (OS) was defined as the time from the date of surgery to death from any cause or last follow-up.

  About five years postoperatively

• Disease-free survival

  Disease-free survival (DFS) was defined as the time from the date of surgery to recurrence, metastasis, and death from any cause.

  About five years postoperatively

Secondary Outcomes (2)

• postoperative adverse events

  within 90 days postoperatively

• perioperative 90-day mortality

  within 90 days postoperatively

Study Arms (2)

Coe-T2DM group

There was a definitive diagnosis of type 2 diabetes mellitus before surgery

Other: Whether there is type 2 diabetes mellitus before surgery

No-T2DM group

There was no clear diagnosis of type 2 diabetes mellitus before surgery

Interventions

Whether there is type 2 diabetes mellitus before surgery OTHER

Patients were grouped according to whether they had type 2 diabetes mellitus before surgery

Coe-T2DM group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with EC who attended the Department of Thoracic Surgery at Daping Hospital and underwent the McKeown MIE procedure performed by the same surgical team were included for evaluation from September 2017 to September 2021.

You may qualify if:

• Patients with a clear pathologic diagnosis of esophageal squamous cell carcinoma;
• Received minimally invasive McKeown procedure;
• Patients with R0 resection (R0: radical resection).

You may not qualify if:

• 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;
• The medical record information is incomplete.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Army Medical Center of the People's Liberation Army

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Diabetes Mellitus; Postoperative Complications

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 27, 2024
• Study Start: February 20, 2024
• Primary Completion: April 20, 2024
• Study Completion: May 20, 2024
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)