Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-02-28

Brief Summary

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This randomized controlled trial (RCT) aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas. Previously reported trials have included all types of pancreatic resections and have include all types of pancreas and have shown no clearcut benefit of octreotide after pancreaticoduodenectomy (PD). Soft pancreas and normal sized duct are the risk factors for fistula following PD. This study's focus is on this select group of patients and aims to assess the role of octreotide in patients with soft pancreas.

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Detailed Description

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Study design: Prospective open labeled randomized trial. AIM: Study aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas.

Conditions

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Pancreatic Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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octreotide

octreotide arm 100mcg for 5 days. control has no octreotide

Group Type EXPERIMENTAL

Inj. Octreotide

Intervention Type DRUG

100 mcg subcutaneously for 5 days

Interventions

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Inj. Octreotide

100 mcg subcutaneously for 5 days

Intervention Type DRUG

Other Intervention Names

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Inj Octride

Eligibility Criteria

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Inclusion Criteria

* soft pancreas, no dilated duct

Exclusion Criteria

* age \> 75 years old
* documented chronic pancreatitis
* previous pancreatic surgery
* previous gastric surgery vagotomy
* documented pancreatic duct dilatation

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No