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

Stopped early · Not applicable

Conditions studied: Pancreatic Pseudocyst

In brief

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.

Key facts

Study ID

NCT00541593

Run by

Baystate Medical Center

People needed

5

Starts

2007-09-01

Expected to finish

2011-06-01

Last updated by the study team

2013-11-07

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Inability to provide informed consent
• Patients who, in the opinion of the investigator, would not be appropriate for enrollment into this experimental research project
• Patients who are deemed to be unstable from a medical standpoint to undergo pancreatic surgery
• Pregnancy

Where it is running

• Baystate Medical Center — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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