Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475911
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The present study is being designed to study the impact and predictive nature of perioperative hyponatremia on post operative outcomes in patients undergoing Major HPB surgeries for cancers Major hepatobiliary-pancreatic surgeries will be defined as follows-
Pancreaticoduodenectomy
Hemihepatectomy or greater with or without caudate lobectomy
Extrahepatic bile duct resection
Extended cholecystectomy
Distal Pancreatectomy with or without splenectomy The primary Objective of the study would be to compare post operative major morbidities and early mortality 90 day in major HPB surgeries done for cancer patients with and without peri-operative hyponatremia 135mmoLL Development of systemic complications and long term outcomes overall survival and disease free survival will also be evaluated
It will be an observational study consisting of both a retrospective arm and a prospective arm All consecutive patients undergoing major HPB surgery from 2010 till 30th June 2024 will be included in the study
Pancreaticoduodenectomy
Hemihepatectomy or greater with or without caudate lobectomy
Extrahepatic bile duct resection
Extended cholecystectomy
Distal Pancreatectomy with or without splenectomy The primary Objective of the study would be to compare post operative major morbidities and early mortality 90 day in major HPB surgeries done for cancer patients with and without peri-operative hyponatremia 135mmoLL Development of systemic complications and long term outcomes overall survival and disease free survival will also be evaluated
It will be an observational study consisting of both a retrospective arm and a prospective arm All consecutive patients undergoing major HPB surgery from 2010 till 30th June 2024 will be included in the study
Detailed Description:
Primary objective To compare post operative major morbidities and early mortality 90 day in major HPB surgeries done for cancer in patients with and without peri-operative hyponatremia 135mmoLL
Secondary objectives To compare the following in patients undergoing major HPB surgeries for cancer in patients with and without peri-operative hyponatremia 135mmoLL
Post operative Systemic complications and
Long term outcomes
OS- POD1 till death last follow up 30th Sep 2024
DFS- Surgical resection till first detected recurrence of cancer or last follow up 30th Sep 2024 without recurrence
Study design- Observational study- Retrospective and prospective
Study period- Data collection will be done from time of ethical clearance till 30th June 2024
Intervention - None
Monitoring and assessment- Clinical profile of the patient and symptoms will be serially followed during the patients post operative OPD visits
STATISTICAL ANALYSIS
1 Continuous variables- with Student t test and Mann Whitney U test as appropriate
2 Categorical data - Chi square or Fischer exact test Besides the above appropriate analysis will be done at the time of final data analysis
3 Significance will be seen at 5 level p005
4 Adequate subgroup analysis and multivariate regression analysis will be done
Adverse effects - No adverse effect is expected to occur out of the study protocol
Stopping rule - Not Valid
Secondary objectives To compare the following in patients undergoing major HPB surgeries for cancer in patients with and without peri-operative hyponatremia 135mmoLL
Post operative Systemic complications and
Long term outcomes
OS- POD1 till death last follow up 30th Sep 2024
DFS- Surgical resection till first detected recurrence of cancer or last follow up 30th Sep 2024 without recurrence
Study design- Observational study- Retrospective and prospective
Study period- Data collection will be done from time of ethical clearance till 30th June 2024
Intervention - None
Monitoring and assessment- Clinical profile of the patient and symptoms will be serially followed during the patients post operative OPD visits
STATISTICAL ANALYSIS
1 Continuous variables- with Student t test and Mann Whitney U test as appropriate
2 Categorical data - Chi square or Fischer exact test Besides the above appropriate analysis will be done at the time of final data analysis
3 Significance will be seen at 5 level p005
4 Adequate subgroup analysis and multivariate regression analysis will be done
Adverse effects - No adverse effect is expected to occur out of the study protocol
Stopping rule - Not Valid
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