Prevention of Chyle-leak After Major Pancreatic Surgery

Helsinki University Central Hospital (HUCH)

Status: Enrolling

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

Treatments: Dietary Supplement: Diet group

Study type: Interventional

Funder types: Other

Identifiers

NCT03167814

HUS/930/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Diet group

Active Comparator group

Description:

Diet group will be on no-fat diet including MCT-oil supplement starting right after surgery according to our pancreas ERAS-protocol.

Treatment:

Dietary Supplement: Diet group

Normal food-group

No Intervention group

Description:

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.