Pancreatic Cancer, ResectedNCT07072897
A Study Comparing Restrictive and Liberal Fluid Therapy During Pancreatecoduodenectomy Surgery
A study testing Fluid bolus administration and Frusemide was given when required in people with Pancreatic Cancer, Resected and Whipple Procedure, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
ancreaticoduodenectomy (also known as PD or the Whipple procedure) is a major surgery often done for conditions like pancreatic cancer. Over the past few decades, doctors around the world have greatly improved surgical techniques, reducing the risk of death after PD from about 24% in the 1980s to less than 2% today in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Resected, Whipple Procedure
- What is being tested?
- Fluid bolus administration and Frusemide was given when required
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNepal
- Study dates
- 1 May 2020to 31 Aug 2021
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who underwent PD at TUTH during the research duration.
- All patients above 18 years.
Who cannot join
- Those not willing to participate in the study.
- All patients with age ≥ 75 years.
- Patients with Chronic renal failure.
- Patients with major Cardiac illness.
- Patients who died within 24 hours of surgery.
- Failure to comply with the regimen due to any reason.
- Those who underwent palliative procedure instead of planned PD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restrictive Versus Liberal Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy: A Prospective Randomized Controlled Study
ancreaticoduodenectomy (also known as PD or the Whipple procedure) is a major surgery often done for conditions like pancreatic cancer. Over the past few decades, doctors around the world have greatly improved surgical techniques, reducing the risk of death after PD from about 24% in the 1980s to less than 2% today in good volume hospitals.
However, even though fewer patients are dying from the surgery, many still face complications after surgery, such as infections, delayed healing, or other problems called as morbidities. These problems can affect 17% to 50% of patients.
Read more
One important factor that may affect recovery is fluid management - the amount of fluids patients receive around the time of surgery.
Traditionally, surgeons gave large amounts of fluid during and after surgery, thinking it helped keep blood pressure and urine output stable. This approach is called liberal fluid therapy. But giving too much fluid can cause swelling, weight gain, and slower recovery.
A newer method, called restrictive fluid therapy, gives smaller, more controlled amounts of fluid to avoid these problems. This approach is new and has shown good results in some studies however the exact role is yet unclear.
At our hospital, we usually use liberal fluid therapy and give fluids based on the treating physician, using these fluids or restricting them as per the treating physician's choice.
So, the study compares these two fluid strategies in patients having PD. Our goal is to find out whether using less fluid (restrictive therapy) could help reduce complications and improve patient outcomes when compared to using more liberal fluids.
- Conditions
- Pancreatic Cancer, Resected, Whipple Procedure
- Being tested
- Fluid bolus administration, Frusemide was given when required
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid bolus administrationOther
fluid boluses 250 ml were given when required
Frusemide was given when requiredOther
fluid is given in a fixed regimen
| Study group | Role | What they receive |
|---|---|---|
| restrictive fluid therapy | Experimental | Restrictive fluid therapy given as bolus of 5ml/kg/hr and the same amount of fluid (5ml/kg/hr) was continued as intraoperative requirement till the end of surgery. Fluid in the restrictive group given postoperatively at the rate of 1ml/kg/hr. This fluid to be given till the 24 hours of the start of surgery which was the study period for this trial. Treating physician was more inclined towards the use of noradrenaline for the maintenance of BP if the urine output was adequate (>0.5ml/kg/hr). Receives: Other: Fluid bolus administration |
| liberal fluid therapy | Active comparator | In the liberal fluid therapy arm, intraoperatively the patients receive a fixed dose of fluid with a bolus of 10ml/kg/hr followed by 10ml/kg/hr till the completion of surgery. The patients receive fluid at the rate of 1.5ml/kg/hr in the postoperative period until 24 hours of the start of surgery.
Fluid boluses of 250ml each to be given anytime during the study period to overcome hypotension or oliguria (<0.5ml/kg/hr) if felt necessary by the physician.
Furosemide 10mg given intravenously anytime if the clinician was suspicious of fluid overload during the study period. Receives: Other: Frusemide was given when required |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications CD≥ IIIb
CD IIIb and more were chosen as major complications as major morbidity occurs when the patient is taken to operating room or ICU to manage these complications.
Measured: 1 month
Secondary outcomes (1)
other complications
Other complications were procedure specific complications like POPF,DGE and other complications that can occur after pancreaticoduodenectomy like Pneumonia, SSI
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 May 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer, ResectedStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romi Dahal, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072897
- Sponsor's protocol ID
- Nepalhealthresearchcouncil2379
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD including demographic data and outcomes will be shared with qualified researchers upon reasonable request
Publications
Myles P, Bellomo R, Corcoran T, Forbes A, Wallace S, Peyton P, Christophi C, Story D, Leslie K, Serpell J, McGuinness S, Parke R; Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): rationale and design for a multicentre randomised trial. BMJ Open. 2017 Mar 3;7(3):e015358. doi: 10.1136/bmjopen-2016-015358.
PubMed 28259855
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrictive Versus Liberal Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07072897
- Acronym / sponsor ID
- Nepalhealthresearchcouncil2379
- Conditions
- Pancreatic Cancer, Resected, Whipple Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 18 Jul 2025 (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.
ancreaticoduodenectomy (also known as PD or the Whipple procedure) is a major surgery often done for conditions like pancreatic cancer. Over the past few decades, doctors around the world have greatly improved surgical techniques, reducing the risk of death after PD from about 24% in the 1980s to less than 2% today in good volume hospitals.
However, even though fewer patients are dying from the surgery, many still face complications after surgery, such as infections, delayed healing, or other problems called as morbidities. These problems can affect 17% to 50% of patients.
One important factor that may affect recovery is fluid management - the amount of fluids patients receive around the time of surgery.
Traditionally, surgeons gave large amounts of fluid during and after surgery, thinking it helped keep blood pressure and urine output stable. This approach is called liberal fluid therapy. But giving too much fluid can cause swelling, weight gain, and slower recovery.
A newer method, called restrictive fluid therapy, gives smaller, more controlled amounts of fluid to avoid these problems. This approach is new and has shown good results in some studies however the exact role is yet unclear.
At our hospital, we usually use liberal fluid therapy and give fluids based on the treating physician, using these fluids or restricting them as per the treating physician's choice.
So, the study compares these two fluid strategies in patients having PD. Our goal is to find out whether using less fluid (restrictive therapy) could help reduce complications and improve patient outcomes when compared to using more liberal fluids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| restrictive fluid therapy | Experimental | Other: Fluid bolus administrationRestrictive fluid therapy given as bolus of 5ml/kg/hr and the same amount of fluid (5ml/kg/hr) was continued as intraoperative requirement till the end of surgery. Fluid in the restrictive group given postoperatively at the rate of 1ml/kg/hr. This fluid to be given till the 24 hours of the start of surgery which was the study period for this trial. Treating physician was more inclined towards the use of noradrenaline for the maintenance of BP if the urine output was adequate (>0.5ml/kg/hr). |
| liberal fluid therapy | Active comparator | Other: Frusemide was given when requiredIn the liberal fluid therapy arm, intraoperatively the patients receive a fixed dose of fluid with a bolus of 10ml/kg/hr followed by 10ml/kg/hr till the completion of surgery. The patients receive fluid at the rate of 1.5ml/kg/hr in the postoperative period until 24 hours of the start of surgery. Fluid boluses of 250ml each to be given anytime during the study period to overcome hypotension or oliguria (<0.5ml/kg/hr) if felt necessary by the physician. Furosemide 10mg given intravenously anytime if the clinician was suspicious of fluid overload during the study period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients who underwent PD at TUTH during the research duration.
- All patients above 18 years.
Key exclusion criteria (7 listed)
- Those not willing to participate in the study.
- All patients with age ≥ 75 years.
- Patients with Chronic renal failure.
- Patients with major Cardiac illness.
- Patients who died within 24 hours of surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid bolus administrationfluid boluses 250 ml were given when required | Other | restrictive fluid therapy |
| Frusemide was given when requiredfluid is given in a fixed regimen | Other | liberal fluid therapy |
Primary outcome
postoperative complications CD≥ IIIb
Time frame: 1 month
CD IIIb and more were chosen as major complications as major morbidity occurs when the patient is taken to operating room or ICU to manage these complications.
1 secondary outcome
other complications
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Background: PubMed 28259855Myles P, Bellomo R, Corcoran T, Forbes A, Wallace S, Peyton P, Christophi C, Story D, Leslie K, Serpell J, McGuinness S, Parke R; Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): rationale and design for a multicentre randomised trial. BMJ Open. 2017 Mar 3;7(3):e015358. doi: 10.1136/bmjopen-2016-015358.
- Peer-reviewed publication related to the study rationale and backgroundLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD including demographic data and outcomes will be shared with qualified researchers upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid bolus administration and Frusemide was given when required in people with Pancreatic Cancer, Resected and Whipple Procedure, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 18 Jul 2025. 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 Nepal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications CD≥ IIIb (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07072897, which also lists 1 linked publication.
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 18 Jul 2025.