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Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

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Rigshospitalet

Status and phase

Completed
Early Phase 1

Conditions

Chylothorax
Lymphatic Diseases

Treatments

Drug: Saline infusion
Drug: Octreotide infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT05683444
P-2020-592

Details and patient eligibility

About

This study aims to investigate whether octreotide, a medication used off-label to treat chylothorax, has a direct effect on human lymphatic drainage. To study the effects of octreotide, the researchers conducted a pre-clinical experiment using human lymphatic vessels mounted in a myograph chamber and a clinical experiment in which a double-blinded, randomized, cross-over trial was conducted in 16 healthy adults. The results of the study will be used to determine the role of octreotide in the treatment of chylothorax and other lymphatic disorders.

Full description

This study aimed to investigate whether octreotide, a medication used off-label to treat chylothorax, has a direct effect on human lymphatic drainage. Chylothorax is a condition in which there is an accumulation of lymphatic fluid in the chest cavity, and the mechanism through which octreotide helps to resolve this condition is not well understood. It has been speculated that the drug may reduce lymph production, but this has not been directly demonstrated. To study the effects of octreotide on human lymphatic vessels, the investigators conducted two experiments: a pre-clinical experiment using human lymphatic vessels mounted in a myograph chamber, and a clinical experiment in which a double-blinded, randomized, cross-over trial was conducted in 16 healthy adults, assessed by using plethysmography and near-infrared fluorescence imaging. The results of the study will be used to determine the role of octreotide in the treatment of chylothorax and to clarify the mechanism through which it acts. It is important to continue researching and developing effective treatments for chylothorax, as it can be a difficult condition to manage and may cause serious complications if left untreated.

Enrollment

16 patients

Sex

All

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

* Healthy

Exclusion criteria

  • No daily medication (except birth control), or allergies towards contrast agents.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

16 participants in 2 patient groups

Healthy participant 1
Other group
Treatment:
Drug: Octreotide infusion
Drug: Saline infusion
Healthy participant 2
Other group
Treatment:
Drug: Octreotide infusion
Drug: Saline infusion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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