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Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts
This study is currently recruiting participants.
Verified by Baystate Medical Center, March 2009
First Received: October 7, 2007   Last Updated: March 5, 2009   History of Changes
Sponsor: Baystate Medical Center
Information provided by: Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00541593
  Purpose

Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. The insertion sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra. Multidisciplinary teams consist of surgeons and gastroenterologists who are collaborating to develop safe and effective surgical techniques via the natural orifice route in order to avoid surgical incisions. Pancreatic pseudocysts are cavities that form typically in the lesser sac following an episode of acute pancreatitis, that may be able to be drained by a variety of techniques, including endoscopically. Chronic pseudocysts often require surgical drainage into the stomach. The medical device company known as "Power Medical Interventions" has a computer-powered surgical stapler which rests on a flexible shaft. Following the insertion of the endoscope, the powered stapler will be passed alongside the endoscope to help the surgeon and gastroenterologist (working as a team) to see where to properly place the stapler. Once the stapler is in position, one jaw of the stapler will be placed into the pseudocyst, and the other jaw will be left in the stomach. The stapler will then be closed and fired, creating a permanent connection between the two hollow spaces and allow the contents of the pseudocyst to drain naturally out into the stomach and intestines. Utilizing this technique, a surgical incision is avoided.

Hypothesis: Patients who undergo the Natural Orifice Translumenal Endoscopic Surgery for treatment of their pancreatic pseudocyst will experience effective treatment with less discomfort and with quicker recovery than standard surgical techniques.


Condition Intervention
Pancreatic Pseudocyst
Procedure: Pancreatic Pseudocystgastrostomy

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • Mortality Morbidity Pain [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • functional longevity [ Time Frame: yearly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: September 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique.
Procedure: Pancreatic Pseudocystgastrostomy
An operation to connect the pancreatic pseudocyst to the stomach so it can drain into the stomach and intestines

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adult (over 18 years old) patients who are able to provide informed consent for this surgical procedure
  2. Patients scheduled to undergo non-emergent surgical treatment removal of pancreatic pseudocyst

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Patients who, in the opinion of the investigator, would not be appropriate for enrollment into this experimental research project
  3. Patients who are deemed to be unstable from a medical standpoint to undergo pancreatic surgery
  4. Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541593

Contacts
Contact: John R Romanelli, MD (413) 794-4025 john.romanelli@bhs.org

Locations
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Karen Christianson, RN, BSN     413-794-5714     karen.christianson@bhs.org    
Principal Investigator: John R Romanelli, MD            
Principal Investigator: David J Desilets, MD, PhD            
Sub-Investigator: David B Earle, MD            
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: John R Romanelli, MD Baystate Medical Center
  More Information

No publications provided

Responsible Party: Bastate Medical Center ( John Romanelli )
Study ID Numbers: 07-164
Study First Received: October 7, 2007
Last Updated: March 5, 2009
ClinicalTrials.gov Identifier: NCT00541593     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
Pancreatic pseudocyst
NOTES

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Pancreatic Cyst
Pancreatic Diseases
Pancreatic Pseudocyst
Cysts

ClinicalTrials.gov processed this record on November 30, 2009