Trial Outcomes & Findings for Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts (NCT NCT00541593)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

One year

Results posted on

2013-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	NOTES Pancreatic Pseudocystgastrostomy Patients Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NOTES Pancreatic Pseudocystgastrostomy Patients n=5 Participants Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
Age Continuous	55.8 years STANDARD_DEVIATION 9.20 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Patients who had the diagnosis, qualified anatomically, and were interested in the research study (and who met inclusion criteria but not exclusion criteria) were enrolled.

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.

Outcome measures

Outcome measures
Measure	NOTES Pancreatic Pseudocystgastrostomy Patients n=5 Participants Pancreatic Pseudocystgastrostomy Patients having NOTES procedure
Mortality	0 participants

Adverse Events

NOTES Pancreatic Pseudocystgastrostomy Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John R. Romanelli

Baystate Medical Center

Phone: (413) 794-3175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place