Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

NCT ID: NCT00826501

Last Updated: 2013-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-01-31

Brief Summary

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.

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.

Conditions

Pancreatic Pseudocysts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy

Group Type: ACTIVE_COMPARATOR

Endoscopic cyst-gastrostomy

Intervention Type: PROCEDURE

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

2

Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic

Group Type: ACTIVE_COMPARATOR

Surgical cyst-gastrostomy

Intervention Type: PROCEDURE

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

Interventions

Endoscopic cyst-gastrostomy

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shyam Varadarajulu

OTHER

Sponsor Role: lead

Responsible Party

Shyam Varadarajulu

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Alabama at birmingham

Birmingham, Alabama, United States

Countries

United States

References

Varadarajulu S, Bang JY, Sutton BS, Trevino JM, Christein JD, Wilcox CM. Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial. Gastroenterology. 2013 Sep;145(3):583-90.e1. doi: 10.1053/j.gastro.2013.05.046. Epub 2013 May 31.

Reference Type: DERIVED

PMID: 23732774 (View on PubMed)

Other Identifiers

F080108003

Identifier Type: -

Identifier Source: org_study_id