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Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts

This study has been terminated.
(SurgAssist device is no longer clinically available.)
Sponsor:
Information provided by (Responsible Party):
John Romanelli, Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00541593
First received: October 7, 2007
Last updated: September 3, 2013
Last verified: September 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 [ Time Frame: One year ] [ Designated as safety issue: Yes ]

    Number of patients who died as a result of the surgery: Death (mortality).

    Please note that pain was previously listed as an outcome measure, but this was edited out of this submission and was not tracked as an outcome measure.



Enrollment: 5
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NOTES pancreatic pseudocystgastrostomy
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541593

Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: John R Romanelli, MD Baystate Medical Center
  More Information

No publications provided

Responsible Party: John Romanelli, Medical Director, Weight Loss Surgery Program, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00541593     History of Changes
Other Study ID Numbers: 07-164
Study First Received: October 7, 2007
Results First Received: June 23, 2011
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
Pancreatic pseudocyst
NOTES

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

ClinicalTrials.gov processed this record on November 27, 2014