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

NCT00541593 | Terminated Results

• 1 other identifier: 07-164
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Pseudocyst

Keywords

Pancreatic pseudocyst; NOTES

Outcome Measures

Primary Outcomes (1)

• Mortality

  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.

  One year

Study Arms (1)

NOTES pancreatic pseudocystgastrostomy

EXPERIMENTAL

Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique.

Procedure: Pancreatic Pseudocystgastrostomy

Interventions

Pancreatic Pseudocystgastrostomy PROCEDURE

An operation to connect the pancreatic pseudocyst to the stomach so it can drain into the stomach and intestines

NOTES pancreatic pseudocystgastrostomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

MeSH Terms

Conditions

Pancreatic Pseudocyst

Condition Hierarchy (Ancestors)

Pancreatic Cyst; Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Limitations and Caveats

Early termination due to the company that made the device going out of business; the company that acquired it chose not to market the device. Given the lack of clinical support, we chose to terminate the study.

Results Point of Contact

• Title: Dr. John R. Romanelli
• Organization: Baystate Medical Center

john.romanelli@bhs.org

(413) 794-3175

Study Officials

• John R Romanelli, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Weight Loss Surgery Program

Study Record Dates

• First Submitted: October 7, 2007
• First Posted: October 10, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 7, 2013
• Results First Posted: November 7, 2013

Record last verified: 2013-09

Locations

US (1)