Clinical trial · Observational
Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Perioperative Hyponatremia
- description
- Perioperative Hyponatremia \<135 mEq/L
- label
- No Perioperative Hyponatremia
- description
- No Perioperative Hyponatremia, i.e s.sodium \>135 mEq/L
Primary outcomes (1)
- measure
- Post operative major morbidities and early mortality (<90 day).
- timeFrame
- Post operative day 90
- description
- 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 outcomes (3)
- measure
- Post operative Systemic complications.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available