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

NCT01372007 | Completed Phase 3

• 1 other identifier: 2011/267
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Carcinoma

Keywords

Rectal carcinoma

Outcome Measures

Primary Outcomes (1)

• % reduction in drain fluid volume over a period of 5 days post study treatment administration in both arms.

  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 Outcomes (2)

• 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.

Study Arms (2)

Lanreotide Autogel 120mg

EXPERIMENTAL

Drug: Lanreotide Autogel 120mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lanreotide Autogel 120mg DRUG

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.

Lanreotide Autogel 120mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female patients
• years
• written informed consent to participate the study
• scheduled to have a total mesorectal excision (TME) for rectumcarcinoma

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Ipsen: collaborator

Study Sites (1)

Universital Hospital Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Piet Pattyn, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 13, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 7, 2016

Record last verified: 2016-10

Locations

BE (1)