Prevention of Chyle-leak After Major Pancreatic Surgery

Pancreatic Cancer Clinical Trial

Official title:

Prevention of Chyle-leak After Major Pancreatic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03167814
• Other study ID #: HUS/930/2017
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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