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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.
University Hospital Ghent
Ghent, Belgium
Percentage of responder patients.
Time frame: At day 7 and day 14.
Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT).
Time frame: day 7, day 14 and day 28 after administration of Lanreotide
Number of days without vomiting episodes
Time frame: day 7, day 14 and day 28 after administration of Lanreotide
Number of daily nausea episodes recorded on diary cards.
Time frame: day 7, day 14 and day 28 after administration of Lanreotide
Intensity of abdominal pain assessed on a visual analogue scale.
Time frame: day 7, day 14 and day 28 after administration of Lanreotide.
Well-being assessed on a visual analogue scale.
Time frame: day 7, day 14 and day 28 after administration of Lanreotide.
Time between first injection and clinical response.
Time frame: day 7, day 14 and day 28 after administration of Lanreotide
Clinical and biological adverse events.
Time frame: day 7, day 14 and day 28 after administration of Lanreotide.
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