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A Study Comparing Restrictive and Liberal Fluid Therapy During Pancreatecoduodenectomy Surgery

NCT07072897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-07-18

No results posted yet for this study

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 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.

Conditions

  • Pancreatic Cancer, Resected
  • Whipple Procedure

Interventions

OTHER

Fluid bolus administration

fluid boluses 250 ml were given when required

OTHER

Frusemide was given when required

fluid is given in a fixed regimen

Sponsors & Collaborators

  • Tribhuvan University Teaching Hospital, Institute Of Medicine.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07072897 on ClinicalTrials.gov