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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03167814
Other study ID # HUS/930/2017
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date December 31, 2025

Study information

Verified date February 2020
Source Helsinki University Central Hospital
Contact Tiina Vuorela, licensiate
Phone +35894711
Email tiina.a.vuorela@hus.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Patient who come for pancreatic surgery and vein resection/reconstruction will be randomized before surgery in two groups. Intervention group will start the no-fat diet right after surgery, with MCT-oil supplement. Diet will be continued up to 14 days after surgery. The control group will start the diet if chyle leak is diagnosed. Criteria of chyle leak in this study is appearance of milky-coloured fluid from the surgical drains in post-operative day 3 and drain fluids triglyceride levels must be high (>1,5 mmol/l). After enough patients have been recruited in the study, patient records are then analyzed to see if the no-fat diet has any effect on incidence of chyle-leak.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Need for a pancreatic resection with vessel resection/reconstruction

Exclusion Criteria:

- No pancreatic and vessel resection needed

- Patients do not want to join the study

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Finland Helsinki university hospital Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chyle-leakage reduced from operating area after surgery Post-operative chyle leak is diagnosed if drain fluids triglyserid content is above normal at post-operative day 3 (> 1,5mmol/l). 2 weeks after surgery or when patient is released from hospital, in the case of prolonged hospital-stay due to complications, is patient data being analyzed
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