Prevention of Chyle-leak After Major Pancreatic Surgery

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Need for a pancreatic resection with vessel resection/reconstruction

Locations
Other Locations
Finland
Helsinki university hospital
RECRUITING
Helsinki
Contact Information
Primary
Tiina Vuorela, licensiate
tiina.a.vuorela@hus.fi
+35894711
Backup
Hanna Seppänen, Phd, Dos
hanna.seppanen@hus.fi
+35894711
Time Frame
Start Date: 2017-08-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 96
Treatments
Active_comparator: Diet group
Diet group will be on no-fat diet including MCT-oil supplement starting right after surgery according to our pancreas ERAS-protocol.
No_intervention: Normal food-group
This study group will follow normal ERAS-protocol after pancreas surgery and start normal diet after surgery. If chyle-leak is diagnosed then it will be treated with the same no-fat diet as the intervention group.
Sponsors
Leads: Helsinki University Central Hospital

This content was sourced from clinicaltrials.gov