Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Pancreatic Pseudocyst |
Procedure: Pancreatic Pseudocystgastrostomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 Morbidity Pain [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- functional longevity [ Time Frame: yearly ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: John R Romanelli, MD | (413) 794-4025 | john.romanelli@bhs.org |
| United States, Massachusetts | |
| Baystate Medical Center | Recruiting |
| Springfield, Massachusetts, United States, 01199 | |
| Contact: Karen Christianson, RN, BSN 413-794-5714 karen.christianson@bhs.org | |
| Principal Investigator: John R Romanelli, MD | |
| Principal Investigator: David J Desilets, MD, PhD | |
| Sub-Investigator: David B Earle, MD | |
| Principal Investigator: | John R Romanelli, MD | Baystate Medical Center |
More Information
No publications provided
| Responsible Party: | John Romanelli, Bastate Medical Center |
| ClinicalTrials.gov Identifier: | NCT00541593 History of Changes |
| Other Study ID Numbers: | 07-164 |
| Study First Received: | October 7, 2007 |
| Last Updated: | March 5, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Baystate Medical Center:
|
Pancreatic pseudocyst NOTES |
Additional relevant MeSH terms:
|
Pancreatic Pseudocyst Pancreatic Cyst Cysts |
Neoplasms Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013