Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

March 15, 2013 updated by: Shyam Varadarajulu
Patients with pancreatitis can develop inflammatory fluid collection around the pancreas called pseudocysts. Pseudocysts may cause abdominal pain when they are more than 6cm in size. These pseudocysts can be treated (drained) by surgery or by endoscopy. Both treatment options are the current standard-of-care at all institutions around the World. The aim of this study is to identify the better of the two techniques, surgery versus endoscopy, for treatment of patients with pancreatic pseudocysts. This will be done by comparing a) the rates of pseudocyst recurrence b) quality of life of patients following treatment and c) cost associated with treatment, between both treatment modalities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer will decrease the severity of abdominal pain when compared to analgesic therapy alone. The specific primary aim of this study is to evaluate the efficacy of EUS-CPN + analgesic therapy (Group 1) in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy (Group 2). The hypothesis will be tested by comparing the changes in reported pain severity between those who receive EUS-CPN in addition to analgesic therapy as compared to analgesic therapy alone.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age > 19yrs
  • able to provide informed consent
  • pancreatic pseudocyst by CT

Exclusion Criteria:

  • age < 19yrs
  • unable to consent
  • pancreatic abscess or necrosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy
Procedure: Endoscopic cyst-gastrostomy
After passing a small camera into the stomach the pseudocyst will be punctured and drained into the stomach by stent placement.
ACTIVE_COMPARATOR: 2
Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic
Procedure: Surgical cyst-gastrostomy
After making an incision in the abdomen the pseudocyst contents will be emptied and the pseudocyst will be sutured to the stomach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life following treatment which will be assessed on a 3-month basis for 24-months using the SF-36 questionnaire
Time Frame: 24 months
24 months
Median time to pseudocyst recurrence at 24 month follow-up.
Time Frame: 24 months
Median time to pseudocyst recurrence at 24 month follow-up.
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare pain medication usage
Time Frame: 24 months
We will attempt to assess the amount of oral/transdermal opiate pain medication used in both arms to determine the efficacy of the neurolytic block.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shyam Varadarajulu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (ESTIMATE)

January 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 15, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F080108003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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