Prevention of Chyle-leak After Major Pancreatic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Complication of Surgical Procedure; Lymph Leakage; Chyle Into Mesentery; Extravasation
• Intervention / Treatment: Dietary supplement: Diet group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiina Vuorela, licensiate; Phone Number: +35894711; Email: tiina.a.vuorela@hus.fi
• Study Contact Backup: Name: Hanna Seppänen, Phd, dos; Phone Number: +35894711; Email: hanna.seppänen@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Hospital
    • Contact: Hanna Seppänen, Phd, dos; Phone Number: +35894711; Email: hanna.seppänen@hus.fi
    • Contact: Tiina Vuorela, LL; Phone Number: +35894711; Email: tiina.a.vuorela@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Hanna Seppänen, Phd, Dos, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HUS/930/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No