- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01372007
Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium, 9000
- Universital Hospital Ghent
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
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.
|
EXPERIMENTAL: Lanreotide Autogel 120mg
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% reduction in drain fluid volume over a period of 5 days post study treatment administration in both arms.
Time Frame: Drain fluid will be checked every day with a minimum of 5 days or until the drain is removed.
|
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.
|
Drain fluid will be checked every day with a minimum of 5 days or until the drain is removed.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the Quality of life of the patient.
Time Frame: This will be evaluated during a hospitalization of approximately 10 days.
|
Patient observation to evaluate Quality of life of the patient, and time of mobilisation after surgery.
Evaluation of the results and the effect on the Health economy.
|
This will be evaluated during a hospitalization of approximately 10 days.
|
Evaluation of the time of mobilisation after surgery.
Time Frame: This will be evaluated during a hospitalization of approximately 10 days.
|
Patient observation to evaluate time of mobilisation after surgery.
Evaluation of the results and the effect on the Health economy.
|
This will be evaluated during a hospitalization of approximately 10 days.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/267
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rectal Carcinoma
-
Amsterdam UMC, location VUmcEnrolling by invitation
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruitingRectal Squamous Cell CarcinomaChina
-
National Cancer Institute (NCI)Active, not recruitingColon Carcinoma | Rectal CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Rectal Carcinoma | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Rectal Mucinous Adenocarcinoma | Rectal Signet Ring Cell Adenocarcinoma | Stage IIA Rectal Cancer AJCC v7 | Stage IIB Rectal Cancer AJCC v7 | Stage IIC Rectal Cancer...United States
-
Fujian Medical UniversityZhejiang Cancer Hospital; Sun Yat-sen University; Fudan University; Peking Union... and other collaboratorsActive, not recruiting
-
International Atomic Energy AgencyCatholic University of the Sacred Heart; University of Cape Town; Tata Memorial... and other collaboratorsUnknownRectal CarcinomaAlgeria, Brazil, Canada, Colombia, Croatia, Cuba, India, Indonesia, Italy, Slovakia, South Africa
-
Sohag UniversityRecruiting
-
Jonsson Comprehensive Cancer CenterNatera, Inc.; The Joseph Drown FoundationRecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8 | Locally...United States
-
National Cancer Institute (NCI)RecruitingHIV Infection | Anal Squamous Cell Carcinoma | Anal Canal Cloacogenic Carcinoma | Stage III Anal Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Anal Margin Squamous Cell Carcinoma | AIDS-Related Anal Carcinoma | Rectal Squamous Cell Carcinoma | Stage I Anal Cancer AJCC... and other conditionsUnited States
Clinical Trials on Lanreotide Autogel 120mg
-
IpsenCompleted
-
IpsenCompletedNon Functioning Entero-pancreatic Endocrine TumourUnited Kingdom, France, Spain, United States, Belgium, Czechia, Italy, Slovakia, Poland
-
Sheba Medical CenterUnknownCongenital HyperinsulinismIsrael
-
IpsenCompleted
-
Asan Medical CenterSamsung Medical Center; Seoul St. Mary's Hospital; Seoul National University... and other collaboratorsRecruitingNeuroendocrine TumorsKorea, Republic of
-
IpsenCompletedGastroenteropancreatic Neuroendocrine TumorChina
-
IpsenCompletedAcromegalyFrance, Switzerland
-
IpsenCompletedMidgut Neuroendocrine Tumours | Pancreatic TumoursSpain, United Kingdom, Denmark, Belgium, Germany, France, Netherlands, Ireland, Italy, Poland
-
IpsenCompletedNeuroendocrine Tumour With Carcinoid SymptomsDenmark, Norway, Sweden
-
IpsenTerminatedIntestinal ObstructionItaly