Clinical trial NCT06475911: Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
Official title: Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients undergoing major HPB surgery from 2010 till 30th June 2024.

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. (\<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.

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. (\<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

Eligibility criteria: Inclusion Criteria:

1. All patients undergoing major HPB cancer surgeries at ILBS from 2010 till 30th June 2024.

Exclusion Criteria:

1. Presence of diuretic (Thiazide, Frusemide), pain killer (Indomethacin, Ketorolac) induced preoperative hyponatremia.
2. Patients with peri-operative diarrhea and vomiting due to infective cause leading to hyponatremia.
3. Patients who did not have a preoperative serum sodium level recorded within 72 hours prior to surgery.
4. Minor HPB cases.

Primary outcomes:
measure: Post operative major morbidities and early mortality (<90 day).
timeFrame: Post operative day 90
Secondary outcomes:
measure: Post operative Systemic complications.
timeFrame: Post operative day 90
measure: Overall Survival
timeFrame: Till 30th Sep 2024
measure: Disease free survival
timeFrame: Till 30th Sep 2024
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: