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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00541593
Recruitment Status : Terminated (SurgAssist device is no longer clinically available.)
First Posted : October 10, 2007
Results First Posted : November 7, 2013
Last Update Posted : November 7, 2013
Information provided by (Responsible Party):
John Romanelli, Baystate Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Pancreatic Pseudocyst Procedure: Pancreatic Pseudocystgastrostomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts
Study Start Date : September 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Mortality [ Time Frame: One year ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00541593

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United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
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Principal Investigator: John R Romanelli, MD Baystate Medical Center
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Responsible Party: John Romanelli, Medical Director, Weight Loss Surgery Program, Baystate Medical Center Identifier: NCT00541593    
Other Study ID Numbers: 07-164
First Posted: October 10, 2007    Key Record Dates
Results First Posted: November 7, 2013
Last Update Posted: November 7, 2013
Last Verified: September 2013
Keywords provided by John Romanelli, Baystate Medical Center:
Pancreatic pseudocyst
Additional relevant MeSH terms:
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Pancreatic Pseudocyst
Pancreatic Cyst
Pancreatic Diseases
Digestive System Diseases