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. (\<135mmoL/L). 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.
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. (\<135mmoL/L) Secondary objectives: To compare the following in patients undergoing major HPB surgeries for cancer in patients with and without peri-operative hyponatremia (\<135mmoL/L) * 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 (p\<0.05). 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 Type
OBSERVATIONAL
Enrollment
500
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
RECRUITINGPost operative major morbidities and early mortality (<90 day).
Post operative major morbidities and early mortality (\<90 day) in major HPB surgeries done for cancer. in patients with and without peri-operative hyponatremia. (\<135mmoL/L).
Time frame: Post operative day 90
Post operative Systemic complications.
Post operative Systemic complications in patients with and without peri-operative hyponatremia.
Time frame: Post operative day 90
Overall Survival
Overall Survival defined as POD1 till death/last follow up in patients with and without peri-operative hyponatremia.
Time frame: Till 30th Sep 2024
Disease free survival
Disease free survival- Surgical resection till first detected recurrence of cancer or last follow-up without recurrence with and without peri-operative hyponatremia.
Time frame: Till 30th Sep 2024
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