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Study · Randomized controlled trial · n = 107 · 2009

4 results

Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae.

Gayral F, Campion JP, Regimbeau JM, Blumberg J, Maisonobe P, Topart P, Wind P

Annals of surgery1 Dec 2009Cited by 34 (Europe PMC)

PMID19953707 (opens in a new tab)DOI10.1097/sla.0b013e3181b2489f (opens in a new tab)PepBankPUB-19953707
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with digestive fistulae, lanreotide increased the probability of a fistula output response versus placebo.

    In plain wordsIn patients with digestive fistulae, lanreotide increased the chance of reduced fistula output compared with placebo.

    Peptide
    Lanreotide
    Outcome
    IncreaseFistula output response
    Study

    n = 107

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    30 mg PR · intramuscular · Single first injection; outcome assessed within 72 hoursAs given in this study (human).

    Measurements

    Responders
    35 patients
    lanreotide
    Response rate
    64.8%
    lanreotide
    Responders
    20 patients
    placebo
    Response rate
    37.7%
    placebo
    Response likelihood ratio
    3.1 fold
    lanreotide versus placebo
    P
    0.006
    reported result

    Source sentences

    Summary
    Following the first double-blind injection, 35 of 54 patients (64.8%) on lanreotide were responders versus 20 of 53 (37.7%) on placebo, ie, a 3.1 times higher response likelihood on lanreotide compared with placebo (P = 0.006).
    2 context sentences
    Summary · context
    Its effectiveness was assessed in patients with simple externalized digestive fistulae in a randomized, doubleblind, placebo-controlled study.
    Summary · context
    Patients demonstrating a reduction of at least 50% of fistula output within 72 hours after a first double-blind intramuscular injection of lanreotide or placebo were considered to be responders (primary end point)
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with digestive fistulae, lanreotide reduced mean fistula output more than placebo at 72 hours.

    In plain wordsIn patients with digestive fistulae, lanreotide reduced fistula output more than placebo at 72 hours.

    Peptide
    Lanreotide
    Outcome
    DecreaseMean fistula output reduction
    Study

    n = 107

    Comparator
    Placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    30 mg PR · intramuscular · Single first injection; outcome assessed at 72 hoursAs given in this study (human).

    Measurements

    Output reduction
    45.1%
    lanreotide
    Output reduction
    8.9%
    placebo
    P
    0.005
    reported result

    Source sentences

    Summary
    Group mean reduction of fistula output at 72 hours was 45.1% and 8.9%, respectively (P = 0.005).
    3 context sentences
    Summary · context
    Following the first double-blind injection, 35 of 54 patients (64.8%) on lanreotide were responders versus 20 of 53 (37.7%) on placebo, ie, a 3.1 times higher response likelihood on lanreotide compared with placebo (P = 0.006).
    Summary · context
    Its effectiveness was assessed in patients with simple externalized digestive fistulae in a randomized, doubleblind, placebo-controlled study.
    Summary · context
    Patients demonstrating a reduction of at least 50% of fistula output within 72 hours after a first double-blind intramuscular injection of lanreotide or placebo were considered to be responders (primary end point)
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with digestive fistulae, lanreotide did not affect fistula closure rate compared with placebo.

    In plain wordsIn patients with digestive fistulae, lanreotide did not change the closure rate compared with placebo.

    Peptide
    Lanreotide
    Outcome
    No significant changeFistula closure rate
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    30 mg PR · intramuscularAs given in this study (human).

    Measurements

    Average closure rate
    77%
    both groups

    Source sentences

    Summary
    Lanreotide compared with placebo had no effect on closure rate which averaged 77% but median time to fistula closure was shorter on lanreotide, based on Kaplan-Meier analysis, although no statistical significance was achieved.
    2 context sentences
    Summary · context
    Its effectiveness was assessed in patients with simple externalized digestive fistulae in a randomized, doubleblind, placebo-controlled study.
    Summary · context
    Patients demonstrating a reduction of at least 50% of fistula output within 72 hours after a first double-blind intramuscular injection of lanreotide or placebo were considered to be responders (primary end point)
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with digestive fistulae, median closure time was shorter with lanreotide than placebo, but the difference was not significant.

    In plain wordsIn patients with digestive fistulae, closure time was shorter with lanreotide than placebo, but the difference was not significant.

    Peptide
    Lanreotide
    Outcome
    No significant changeTime to fistula closure
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    30 mg PR · intramuscularAs given in this study (human).

    Source sentences

    Summary
    Lanreotide compared with placebo had no effect on closure rate which averaged 77% but median time to fistula closure was shorter on lanreotide, based on Kaplan-Meier analysis, although no statistical significance was achieved.
    2 context sentences
    Summary · context
    Its effectiveness was assessed in patients with simple externalized digestive fistulae in a randomized, doubleblind, placebo-controlled study.
    Summary · context
    Patients demonstrating a reduction of at least 50% of fistula output within 72 hours after a first double-blind intramuscular injection of lanreotide or placebo were considered to be responders (primary end point)

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00729313

Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae

Ipsenn = 111Apr 2000 to Apr 2005

Digestive Fistulae

Trial pageClinicalTrials.govUpdated 4 Mar 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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