Clinical trial NCT03167814: Prevention of Chyle-leak After Major Pancreatic Surgery
Official title: Prevention of Chyle-leak After Major Pancreatic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymph Leakage
Chyle Into Mesentery; Extravasation
Pancreatic Cancer
Complication of Surgical Procedure
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who fill our study ciriteria are asked to join in on the study and then they are randomized in to two groups, interventional and control group
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Chyle-leakage reduced from operating area after surgery
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki university hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Hanna Seppänen, Phd, Dos
role: PRINCIPAL_INVESTIGATOR
References: