Impact of Peri-Operative Hyponatremia on Postoperative Ou... | NCT06475911

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

NCT06475911

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Unknown status

Last Update Posted

Jun 26, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Carcinoma

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2023Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Jun 20, 2024

First Submission Date that Met QC Criteria

Jun 25, 2024

First Posted Date

Jun 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2024

Last Update Posted Date

Jun 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Perioperative Hyponatremia		Perioperative Hyponatremia <135 mEq/L
No Perioperative Hyponatremia		No Perioperative Hyponatremia, i.e s.sodium >135 mEq/L

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr Sambhav Gupta, MS	Contact	01146300000		drsambhavgupta@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Liver and Biliary Sciences	Recruiting	New Delhi	National Capital Territory of Delhi	110070	India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002277	Carcinoma

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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