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Completed

NCT Number: NCT00826501

Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

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.

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Key information

Conditions

Pancreatic Pseudocysts Cysts Digestive System Diseases Neoplasms Pancreatic Cyst Pancreatic Diseases Pancreatic Pseudocyst

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at birmingham

Birmingham, Alabama, 35244, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Endoscopic cyst-gastrostomy

Procedure

After passing a small camera into the stomach the pseudocyst will be punctured and drained into the stomach by stent placement.

Surgical cyst-gastrostomy

Procedure

After making an incision in the abdomen the pseudocyst contents will be emptied and the pseudocyst will be sutured to the stomach.

Primary outcomes

  1. Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy

    Time frame: 24 months

Secondary outcomes

  1. 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

  2. Median time to pseudocyst recurrence at 24 month follow-up.

    Time frame: 24 months

    Median time to pseudocyst recurrence at 24 month follow-up.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shyam Varadarajulu

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2012
First posted
Jan 22, 2009
Registry last updated
Mar 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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