Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts
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.
|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|
- 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.
|Study Start Date:||September 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00541593
|United States, Massachusetts|
|Baystate Medical Center|
|Springfield, Massachusetts, United States, 01199|
|Principal Investigator:||John R Romanelli, MD||Baystate Medical Center|