Clinical Trial: Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts
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.
Detailed Summary:
Introduction: Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. Multiple animal studies utilizing similar techniques are ongoing at several institutions, including Baystate Medical Center. These 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. These pseudocysts may become infected, and may have detrimental outcomes caused by their mass effect on the stomach and/or small intestine. Pseudocysts are able to be drained by a variety of techniques, including endoscopically. Chronic pseudocysts often require surgical drainage into the stomach or jejunum as they may contain solid material that does not drain. Typically, cystgastrostomies or cystenterotomies are performed utilizing an abdominal incision with subsequent suturing or stapling.
The medical device company known as "Power Medical Interventions" has a computer-powered surgical stapler which rests on a flexible shaft. There has been subsequent development of a linear version of this stapler which was designed for gastrointestinal anastomosis which will be utilized in this research project known as a "powered stapler".
An endoscope would be inserted in the mouth, and down into the stomach after the induction of general anesthesia. 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 th
Sponsor: Baystate Medical Center
Current Primary Outcome: 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.
Original Primary Outcome: Mortality Morbidity Pain [ Time Frame: One year ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Baystate Medical Center
Dates:
Date Received: October 7, 2007
Date Started: September 2007
Date Completion:
Last Updated: September 3, 2013
Last Verified: September 2013
