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

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 the stapler. If a connection has been previously made between the stomach and pseudocyst, the stapler will be maneuvered into the proper position. If a connection has not yet been made, this will be done during the procedure with the aid of an endoscopic ultrasound probe passed through the mouth. 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. The stapler and the endoscope are then removed and the anesthesia is allowed to wear off. Utilizing this technique, a surgical incision is avoided.

Primary Objective: The primary objective of this study is to demonstrate that the Natural Orifice Translumenal Endoscopic Surgery (NOTES) technique is as effective as standard surgical technique for the permanent drainage of pancreatic pseudocysts.