Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma

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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Dr Sambhav Gupta, MS; Phone Number: 01146300000; Email: drsambhavgupta@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver and Biliary Sciences
      • Contact: Dr Sambhav Gupta, MS; Phone Number: 9354110823; Email: drsambhavgupta@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients undergoing major HPB surgery from 2010 till 30th June 2024.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Perioperative Hyponatremia; Perioperative Hyponatremia <135 mEq/L
No Perioperative Hyponatremia; No Perioperative Hyponatremia, i.e s.sodium >135 mEq/L

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post 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).	Post operative day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative Systemic complications.	Post operative Systemic complications in patients with and without peri-operative hyponatremia.	Post operative day 90
Overall Survival	Overall Survival defined as POD1 till death/last follow up in patients with and without peri-operative hyponatremia.	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.	Till 30th Sep 2024

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: ILBS-Cancer-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No