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Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

NCT04418739 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2022-06-16

No results posted yet for this study

Summary

Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes are broadly categorized to disease-related, patient-related and operative factors. Whereas an inexhaustible list of study exists on looking at reducing PD complication rates with respect to the above-mentioned factors, it was only recently that more attention has been given to the impact of perioperative and intraoperative fluid regimes on PD outcomes. This study takes interest in the impact of intraoperative fluid regimes on PD outcomes. The objective of this investigation is to compare the outcomes with the use of intraoperative intravenous human albumin versus standard intraoperative fluid regimes.

Conditions

  • Pancreaticoduodenectomy
  • Pancreatic Fistula
  • Delayed Gastric Emptying
  • Pancreatic Cancer
  • Anastomotic Leak

Interventions

DRUG

Human albumin

Intravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour

Sponsors & Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

    lead OTHER

Principal Investigators

  • Ian Chik · Universiti Kebangsaan Malaysia Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-27
Primary Completion
2022-11-26
Completion
2022-11-26

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

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 NCT04418739 on ClinicalTrials.gov