Prevention of Chyle-leak After Major Pancreatic Surgery

NCT ID: NCT03167814

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Diet group

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

Group Type: ACTIVE_COMPARATOR

Diet group

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tiina Vuorela

MD, PHd student, Junior surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanna Seppänen, Phd, Dos

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Helsinki university hospital

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Tiina Vuorela, licensiate

Role: CONTACT

tiina.a.vuorela@hus.fi

+35894711

Hanna Seppänen, Phd, Dos

Role: CONTACT

hanna.seppanen@hus.fi

+35894711

Facility Contacts

Tiina Vuorela, LL

Role: primary

tiina.a.vuorela@hus.fi

+35894711

Hanna Seppänen, Phd, dos

Role: backup

hanna.seppänen@hus.fi

+35894711

Other Identifiers

HUS/930/2017

Identifier Type: -

Identifier Source: org_study_id