Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01372007
First received: June 8, 2011
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Rectal Carcinoma
Drug: Lanreotide Autogel 120mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • % 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluation of the Quality of life of the patient. [ Time Frame: This will be evaluated during a hospitalization of approximately 10 days. ] [ Designated as safety issue: No ]
    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.

  • Evaluation of the time of mobilisation after surgery. [ Time Frame: This will be evaluated during a hospitalization of approximately 10 days. ] [ Designated as safety issue: No ]
    Patient observation to evaluate time of mobilisation after surgery. Evaluation of the results and the effect on the Health economy.


Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lanreotide Autogel 120mg Drug: 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.
Placebo Comparator: Placebo Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372007

Contacts
Contact: Piet Pattyn, Md, PhD piet.pattyn@ugent.be
Contact: Saskia De Groote saskia.degroote@uzgent.be

Locations
Belgium
Universital Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Piet Pattyn, PhD, MD         
Sub-Investigator: Inge Vandenbroucke         
Sub-Investigator: Saskia De Groote         
Principal Investigator: W. Ceelen, PhD, MD         
Principal Investigator: Y. Van Nieuwenhove, PhD, MD         
Principal Investigator: D. Van de Putte, PhD, MD         
Sponsors and Collaborators
University Hospital, Ghent
Ipsen
Investigators
Principal Investigator: Piet Pattyn, MD, PhD University Hospital, Ghent
  More Information

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01372007     History of Changes
Other Study ID Numbers: 2011/267
Study First Received: June 8, 2011
Last Updated: January 29, 2013
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:
Rectal carcinoma

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014