Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent

NCT01239056 | Completed Results

• 1 other identifier: Pancreatic Pseudocyst
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.

Conditions

Pancreatic Pseudocysts

Outcome Measures

Primary Outcomes (1)

• Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen

  Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst . Technical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst.

  baseline

Secondary Outcomes (2)

• Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).

  6 to 12 weeks after baseline

• Adverse Events

  1 year

Study Arms (1)

Pancreatic Pseudocysts

All adult patients who have a clinical indication to undergo an endoscopic drainage of a pancreatic pseudocyst.

Procedure: Endoscopy

Interventions

Endoscopy PROCEDURE

Endoscopic drainage of a pancreatic pseudocyst using a metal stent per medical indication.

Pancreatic Pseudocysts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have a medical indication for endoscopic drainage of pancreatic pseudocyst and are referred for the procedure as part of their standard medical care will be considered for the study.

You may qualify if:

• Subject is 18 years or older
• Subject has pancreatic pseudocyst
• Subject has medical indication for drainage of the pancreatic pseudocyst
• Subject must be able to give informed consent

You may not qualify if:

• Any contraindication to endoscopic pseudocyst drainage
• Subject is unable to give informed consent

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Shands UF Endoscopy

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Pancreatic Pseudocyst

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Pancreatic Cyst; Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Peter V. Draganov
• Organization: University of Florida

Peter.Draganov@medicine.ufl.edu

(352) 273-9472

Study Officials

• Peter V draganov, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 11, 2010
• Study Start: August 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 7, 2015
• Results First Posted: August 21, 2015

Record last verified: 2015-08

Locations

US (1)