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Prevention of Chyle-leak After Major Pancreatic Surgery

NCT03167814 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-02-18

No results posted yet for this study

Summary

Chyle is lymphatic fluid present in the wall of the intestine. It flows trough lymphatic vessels to cisterna chyli and to venous circulation carrying lymphatic fluid, long-chain triglyceride fatty acids and proteins, fatty soluble vitamins and electrolytes. Lymphatic vessels are at risk of damage in pancreatic surgery and especially when there is vein/artery resection and reconstruction at the same time. Chyle leak can be seen in post-operative patients when there is milky substance coming out of the surgical drains and drain fluids triglyceride level is high (\>1,5 mmol/l). Patients with chyle leak are at risk of dehydration, malnutrition, sepsis and prolonged stay at the hospital. Usually treatment of chyle leak is with drains and no-fat diet up to 14 days after surgery. Sometimes combined with somatostatine-analogue-treatment. In this study investigators are randomizing patients with major pancreatic surgery in to two groups. Intervention group will start no-fat diet, including MCT-oil, right after surgery up to 2 weeks. And control group will start the diet if chyle-leak is seen. End goal is to reduce chyle-leaks in post-operative patients and analyze if it has an effect on patients prognosis.

Conditions

  • Lymph Leakage
  • Chyle Into Mesentery; Extravasation
  • Pancreatic Cancer
  • Complication of Surgical Procedure

Interventions

DIETARY_SUPPLEMENT

Diet group

In the diet, there is no long-chain triglycerides. Fat and protein needs are met with adding medium-chain-fat acid as oil and protein supplements to the diet. Diet has been constructed together with clinical nutrition specialist.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Hanna Seppänen, Phd, Dos · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Finland

Study Locations

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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 NCT03167814 on ClinicalTrials.gov