Prevention of Chyle-leak After Major Pancreatic Surgery

NCT03167814 | Unknown

• 1 other identifier: HUS/930/2017
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Diet group

ACTIVE COMPARATOR

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

Normal food-group

NO INTERVENTION

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.

Interventions

Diet group DIETARY_SUPPLEMENT

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.

Diet group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Need for a pancreatic resection with vessel resection/reconstruction

You may not qualify if:

• No pancreatic and vessel resection needed
• Patients do not want to join the study

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki university hospital

Helsinki, Finland

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Hanna Seppänen, Phd, Dos

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiina Vuorela, licensiate

CONTACT

+35894711; tiina.a.vuorela@hus.fi

Hanna Seppänen, Phd, Dos

CONTACT

+35894711; hanna.seppanen@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHd student, Junior surgeon

Model Details: 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

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 30, 2017
• Study Start: August 1, 2017
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)