A Study Comparing Restrictive And Liberal Fluid Therapy During Pancreatecoduodenectomy Surgery

Study Overview

A Study Comparing Restrictive and Liberal Fluid Therapy During Pancreatecoduodenectomy Surgery

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.

N/A

Pancreatic Cancer, Resected
Whipple Procedure

OTHER: Fluid bolus administration
OTHER: Frusemide was given when required

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Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-06-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-09
First Submitted that Met QC Criteria 2025-07-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-18
First Posted (ACTUAL) 2025-07-18	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: restrictive fluid therapy 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 t	OTHER: Fluid bolus administration fluid boluses 250 ml were given when required
ACTIVE_COMPARATOR: liberal fluid therapy 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 peri	OTHER: Frusemide was given when required fluid is given in a fixed regimen

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: restrictive fluid therapy

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 t

OTHER: Fluid bolus administration

fluid boluses 250 ml were given when required

ACTIVE_COMPARATOR: liberal fluid therapy

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 peri

OTHER: Frusemide was given when required

fluid is given in a fixed regimen

Primary Outcome Measures	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures	Measure Description	Time Frame
other complications	Other complications were procedure specific complications like POPF,DGE and other complications that can occur after pancreaticoduodenectomy like Pneumonia, SSI	1 month

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

All patients who underwent PD at TUTH during the research duration.
All patients above 18 years.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

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Clinical Trial Record