Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333665
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-21
Brief Title:
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
Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Organization:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor good glycemic control HbA1c70 is associated with improved survival
Detailed Description:
Esophageal cancer is one of the major components of the global cancer burden According to the Global Cancer Statistics 2020 report in 2020 esophageal cancer ranked ninth in the world in incidence 604100 new cases and sixth in overall mortality 544076 deaths In China esophageal cancer ranked fifth among cancer-related causes of death in 2020 with more than 90 of esophageal cancers being esophageal squamous cell carcinoma ESCC Until now surgery-based comprehensive treatment has remained the main mode of treatment for patients with potentially curable localized esophageal cancer However despite efforts to advance treatment the five-year survival rate for patients with esophageal cancer after surgery is still low so it is important to identify prognosis-related factors
Diabetes is a global health problem that has reached alarming levels In 2019 nearly half a billion people worldwide 93 of adults aged 20-79 years had diabetes with approximately 20 in the age group aged 60-75 years the main incidence group of esophageal cancer Diabetes mellitus is a wasting systemic disease associated with poor outcomes across multiple disease processes and is one of the greatest challenges facing healthcare systems worldwide For malignant tumors diabetes is not only one of the causes but also one of the risk factors for low survival Although other cancer specialties eg colon pancreatic breast are associated with poor oncology outcomes it may be due to decreased immunity and increased systemic inflammation in patients with diabetes However there is controversy regarding the prognostic role of diabetes mellitus in patients undergoing surgery for esophageal cancer There is evidence that patients with diabetes have an increased risk of cancer recurrence and death after surgery compared with non-diabetic controls However some studies have shown no significant association between T2DM and postoperative complications suggesting that diabetes is not an independent risk factor for survival
Metformin a member of the biguanide family is commonly used as an oral antihyperglycemic agent that reduces cancer risk and improves prognosis for a variety of cancers In recent years the use of metformin has improved survival in patients with malignant tumors For patients with esophageal squamous cell carcinoma ESCC several molecular mechanisms have been shown to inhibit tumor progression for example by inhibiting the growth of esophageal cancer cells Metformin has also been shown to have a beneficial prognostic effect on some other tumors such as colon lung and prostate cancers in some studies The association between metformin use and mortality in patients undergoing surgery for esophageal cancer has been analyzed with conflicting results A study by Van De Voorde et al showed that the use of metformin was associated with significantly better distant metastasis-free survival and overall survival In contrast the results of Spierings et al showed that metformin use did not result in higher pathologic response rates or improved overall survival or disease-free survival They believe that contrary to the assumptions of other tumor types metformin may not have a beneficial effect on esophageal cancer
Studies have shown that T2DM does not appear to have a significant effect on the long-term survival of esophageal cancer patients undergoing esophagectomy In contrast it may be more important to control blood glucose levels in patients with T2DM undergoing esophagectomy At the same time a large number of studies have confirmed that diabetic patients with poor glycemic control have a higher complication rate after esophageal cancer surgery especially anastomotic leakage
In summary there is controversy as to whether type II diabetes mellitus will result in adverse short- and long-term outcomes for 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 andor good glycemic control HbA1c70 is associated with improved survival
Diabetes is a global health problem that has reached alarming levels In 2019 nearly half a billion people worldwide 93 of adults aged 20-79 years had diabetes with approximately 20 in the age group aged 60-75 years the main incidence group of esophageal cancer Diabetes mellitus is a wasting systemic disease associated with poor outcomes across multiple disease processes and is one of the greatest challenges facing healthcare systems worldwide For malignant tumors diabetes is not only one of the causes but also one of the risk factors for low survival Although other cancer specialties eg colon pancreatic breast are associated with poor oncology outcomes it may be due to decreased immunity and increased systemic inflammation in patients with diabetes However there is controversy regarding the prognostic role of diabetes mellitus in patients undergoing surgery for esophageal cancer There is evidence that patients with diabetes have an increased risk of cancer recurrence and death after surgery compared with non-diabetic controls However some studies have shown no significant association between T2DM and postoperative complications suggesting that diabetes is not an independent risk factor for survival
Metformin a member of the biguanide family is commonly used as an oral antihyperglycemic agent that reduces cancer risk and improves prognosis for a variety of cancers In recent years the use of metformin has improved survival in patients with malignant tumors For patients with esophageal squamous cell carcinoma ESCC several molecular mechanisms have been shown to inhibit tumor progression for example by inhibiting the growth of esophageal cancer cells Metformin has also been shown to have a beneficial prognostic effect on some other tumors such as colon lung and prostate cancers in some studies The association between metformin use and mortality in patients undergoing surgery for esophageal cancer has been analyzed with conflicting results A study by Van De Voorde et al showed that the use of metformin was associated with significantly better distant metastasis-free survival and overall survival In contrast the results of Spierings et al showed that metformin use did not result in higher pathologic response rates or improved overall survival or disease-free survival They believe that contrary to the assumptions of other tumor types metformin may not have a beneficial effect on esophageal cancer
Studies have shown that T2DM does not appear to have a significant effect on the long-term survival of esophageal cancer patients undergoing esophagectomy In contrast it may be more important to control blood glucose levels in patients with T2DM undergoing esophagectomy At the same time a large number of studies have confirmed that diabetic patients with poor glycemic control have a higher complication rate after esophageal cancer surgery especially anastomotic leakage
In summary there is controversy as to whether type II diabetes mellitus will result in adverse short- and long-term outcomes for 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 andor good glycemic control HbA1c70 is associated with improved survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None