Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma
Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma
Sponsors
Source
University Hospital, Ghent
Oversight Info
Has Dmc
No
Brief Summary
Total mesorectal excision (TME) is a precise dissection of the rectum and all para-rectal
lymph nodes within the mesorectal envelope. It is becoming universally recognized and
accepted as the standard technique for surgical excision of rectum carcinomas. TME results in
lowest rates of local recurrence, especially when combined with pre-operative
chemo-radiotherapy.
Especially after pre-operative chemo-radiotherapy, the post-operative drainage may be
important. The quick decrease of this drainage will enable the early mobilisation of the
patient and may shorten the time of hospitalization. If this decrease in fluid production can
be achieved, it will have a positive effect on the Quality of Life of the patient and will
ensure health economic savings by reduction of hospitalization time and resources.
Somatostatin analogues have shown to be able to decrease the secretion of numerous types of
bodily fluids.
The aim of this study is to investigate if lanreotide Autogel 120mg is capable to reduce the
fluid discharge in patients that underwent a TME for rectumcarcinoma.
Lanreotide Autogel 120mg compared to placebo, administered post-surgery on the fluid
discharge in the drain of the patient that underwent a total mesorectum excision (TME) for
rectal carcinoma. Patient planned to have a TME will be asked to participate in the study.
When they have provided written informed consent, they will be randomized 1:1 to receive
either placebo or lanreotide autogel 120mg. Drain fluid will be checked for hematocrit daily
post-surgery. Once hematocrit levels of the drain fluid are <10%, study medication or placebo
will be administered. After administration the volume of the drain fluid will be measured
every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24
hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride
analysis afterwards. If the patient has a hematocrit >10% in his drain fluid for a period of
5 days, this patient can not be randomized.
Overall Status
Completed
Start Date
2011-07-01
Completion Date
2014-12-01
Primary Completion Date
2014-12-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
% reduction in drain fluid volume over a period of 5 days post study treatment administration in both arms. |
Drain fluid will be checked every day with a minimum of 5 days or until the drain is removed. |
Secondary Outcome
Measure |
Time Frame |
|
Evaluation of the Quality of life of the patient. |
This will be evaluated during a hospitalization of approximately 10 days. |
|
Evaluation of the time of mobilisation after surgery. |
This will be evaluated during a hospitalization of approximately 10 days. |
Enrollment
24
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Drain fluid will be checked for hematocrit daily post-surgery. Once hematocrit levels of the drain fluid are <10%, study medication (0.246mg lanreotide base/mg solution) will be administered. After administration the volume of the drain fluid will be measured every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24 hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride analysis afterwards.
Arm Group Label
Lanreotide Autogel 120mg
Intervention Type
Drug
Intervention Name
Description
Drain fluid will be checked for hematocrit daily post-surgery. Once hematocrit levels of the drain fluid are <10%, placebo (Sodiumchloride 0,9% 1 ampoule) will be administered. After administration the volume of the drain fluid will be measured every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24 hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride analysis afterwards.
Arm Group Label
Placebo
Eligibility
Criteria
Inclusion Criteria:
- male and female patients
- 18-75 years
- written informed consent to participate the study
- scheduled to have a total mesorectal excision (TME) for rectumcarcinoma
Exclusion Criteria:
- patients with a known intolerance for somatostatin analogues, lanreotide or any of
it's excipients
- patients younger than 18 years
- patients unable to provide written informed consent
- patients who received somatostatin or any of it's analogues the last 30 days before
the start of the study
- Pregnant and breast-feeding women
- Women not using contraception
Gender
All
Minimum Age
18 Years
Maximum Age
75 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Piet Pattyn, MD, PhD |
Principal Investigator |
University Hospital, Ghent |
Location
Facility |
|
Universital Hospital Ghent Ghent 9000 Belgium |
Location Countries
Country
Belgium
Verification Date
2016-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Lanreotide
Angiopeptin
Arm Group
Arm Group Label
Lanreotide Autogel 120mg
Arm Group Type
Experimental
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)
Study First Submitted
June 8, 2011
Study First Submitted Qc
June 10, 2011
Study First Posted
June 13, 2011
Last Update Submitted
October 6, 2016
Last Update Submitted Qc
October 6, 2016
Last Update Posted
October 7, 2016
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.