Malignant Intestinal Obstruction
Conditions
Keywords
Malignant intestinal obstruction in inoperable patients
Brief summary
The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This effect will be evaluated by the percentage of responder patients 7 and 14 days after one administration of lanreotide 120 mg. (A responder patient will be defined either as a patient experiencing \< or= 1 vomiting episode per day during at least three consecutive days or as a patient in whom NGT has been removed without any vomiting recurrence during at least three consecutive days) The total number of visits will depend on the clinical situation, 5 visits are obligatory: Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28 Inclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs, diary cards, VAS scale, cc medication, blood sample Visit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of biochemical analyse, adverse events, cc medication In between the visits, the patient will keep and fill out his diary and VAS scale
Interventions
DRUGLanreotide (acetate)
Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.
Sponsors
University Hospital, Ghent
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PIC * \>= 18 years at time of enrolment * Diagnosis of a digestive obstruction of malignant origin * Diagnosis of peritoneal carcinomatosis confirmed by a ct scan within the previous 3 months * Inoperability as decided after surgical consultation
Exclusion criteria
* Operable obstruction * Bowel obstruction that can be explained by a non malignant cause * Signs of bowel obstruction * Prior treatment with somatostatin analogues within the previous 60 days * Known hypersensitivity to any of the test materials or related compounds * Previous enrolment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of responder patients. | At day 7 and day 14. |
Secondary
| Measure | Time frame |
|---|---|
| Number of days without vomiting episodes | day 7, day 14 and day 28 after administration of Lanreotide |
| Number of daily nausea episodes recorded on diary cards. | day 7, day 14 and day 28 after administration of Lanreotide |
| Intensity of abdominal pain assessed on a visual analogue scale. | day 7, day 14 and day 28 after administration of Lanreotide. |
| Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT). | day 7, day 14 and day 28 after administration of Lanreotide |
| Time between first injection and clinical response. | day 7, day 14 and day 28 after administration of Lanreotide |
| Clinical and biological adverse events. | day 7, day 14 and day 28 after administration of Lanreotide. |
| Well-being assessed on a visual analogue scale. | day 7, day 14 and day 28 after administration of Lanreotide. |
Countries
Belgium
Outcome results
None listed