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Completed

NCT Number: NCT07072897

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tribhuvan University Teaching Hospital

Kathmandu, Bagmati, 44600, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Fluid bolus administration

Other

fluid boluses 250 ml were given when required

Frusemide was given when required

Other

fluid is given in a fixed regimen

Primary outcomes

  1. 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.

Secondary outcomes

  1. other complications

    Time frame: 1 month

    Other complications were procedure specific complications like POPF,DGE and other complications that can occur after pancreaticoduodenectomy like Pneumonia, SSI

Sponsors and collaborators

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Other

Registry information

Official study title

Restrictive Versus Liberal Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy: A Prospective Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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