CarcinomaNCT06475911
Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
An observational study of Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 23 Oct 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients undergoing major HPB surgery from 2010 till 30th June 2024.
Who may be able to join
- All patients undergoing major HPB cancer surgeries at ILBS from 2010 till 30th June 2024.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Sambhav Gupta, MS, 9354110823, drsambhavgupta@gmail.com
About this study
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.
Read the 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:
- Continuous variables- with Student t test and Mann Whitney U test as appropriate.
- Categorical data - Chi square or Fischer exact test. Besides the above, appropriate analysis will be done at the time of final data analysis.
- Significance will be seen at 5 % level (p<0.05).
- 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
- Conditions
- Carcinoma
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Hyponatremia | Perioperative Hyponatremia <135 mEq/L | |
| No Perioperative Hyponatremia | No Perioperative Hyponatremia, i.e s.sodium >135 mEq/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post operative day 90
Secondary outcomes (3)
Post operative Systemic complications.
Post operative Systemic complications in patients with and without peri-operative hyponatremia.
Measured: Post operative day 90
Overall Survival
Overall Survival defined as POD1 till death/last follow up in patients with and without peri-operative hyponatremia.
Measured: 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.
Measured: Till 30th Sep 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start23 Oct 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475911
- Sponsor's protocol ID
- ILBS-Cancer-01
- Status last verified
- Apr 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
- ClinicalTrials.gov ID
- NCT06475911
- Acronym / sponsor ID
- ILBS-Cancer-01
- Conditions
- Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Continuous variables- with Student t test and Mann Whitney U test as appropriate.
- Categorical data - Chi square or Fischer exact test. Besides the above, appropriate analysis will be done at the time of final data analysis.
- Significance will be seen at 5 % level (p<0.05).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative Hyponatremia | – | –Perioperative Hyponatremia <135 mEq/L |
| No Perioperative Hyponatremia | – | –No Perioperative Hyponatremia, i.e s.sodium >135 mEq/L |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients undergoing major HPB surgery from 2010 till 30th June 2024.
Key inclusion criteria (1 listed)
- All patients undergoing major HPB cancer surgeries at ILBS from 2010 till 30th June 2024.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post operative major morbidities and early mortality (<90 day).
Time frame: Post operative day 90
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).
3 secondary outcomes
Post operative Systemic complications.
Time frame: Post operative day 90
Overall Survival
Time frame: Till 30th Sep 2024
Disease free survival
Time frame: Till 30th Sep 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Sambhav Gupta, MS (01146300000, drsambhavgupta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative major morbidities and early mortality (<90 day). (time frame: Post operative day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.