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

NCT06475911 | Recruiting

• 1 other identifier: ILBS-Cancer-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post operative Systemic complications.

  Post operative day 90

• Overall Survival

  Till 30th Sep 2024

• Disease free survival

  Till 30th Sep 2024

Study Arms (2)

Perioperative Hyponatremia

Perioperative Hyponatremia \<135 mEq/L

No Perioperative Hyponatremia

No Perioperative Hyponatremia, i.e s.sodium \>135 mEq/L

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Dr Sambhav Gupta, MS

CONTACT

01146300000; drsambhavgupta@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: October 23, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-04

Locations

IN (1)