Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-12-31

Brief Summary

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The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized studies have been conducted on the influence of pancreatic duct stenting for the patients' benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether pancreatic duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker clinical recovery and avoidance of recurrence of pancreatic pseudocysts.

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Detailed Description

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Conditions

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Chronic Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No stenting

Control group, no stenting of the pancreatic duct in case of a disrupted duct

Group Type NO_INTERVENTION

No interventions assigned to this group

Pancreatic duct stenting

in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm

Group Type ACTIVE_COMPARATOR

pancreatic duct stenting

Intervention Type PROCEDURE

in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.

Interventions

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pancreatic duct stenting

in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* pancreatic pseudocyst, at least 6 cm in diameter
* symptomatic pancreatic pseudocyst
* increasing size of pancreatic pseudocyst within 6 weeks

Exclusion Criteria

* Pregnancy
* Age less than 18 years
* Postoperative status preventing access to papilla
* Allergy to contrast preventing from ERP
* Missing informed consent to study
* PTT above 1.5 times of normal, unless substituted
* Platelet count less than 50.000/µl, unless substituted
* Pancreatic ascites or fistula
* Life expectancy less than 2 years
* Percutaneously drained cysts are not part of the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No