Title: First Randomized Controlled Trial of Flexible Endoscopic Mucomyotomy of Zenkers Diverticulum (ZD): APC Versus Needle-Knife Cutting
Abstract: Background: Flexible endoscopic treatment has been established as a minimally invasive method for treatment of symptomatic ZD. Randomized controlled trials of different endoscopic methods have not been reported, yet. Aim: To compare the efficacy and safety of APC versus needle knife incision for mucomyotomy. Methods: 40 consecutive patients (pts.) with symptomatic ZD referred to our unit from 2/06 to 4/08 were randomized to APC or needle-knife (NK) mucomyotomy. Primary end point was the number of sessions necessary to achieve symptom relief and pts. satisfaction. Before treatment and during follow-up all pts. were asked for evaluation of symptoms (frequency/intensity of discomfort) by numeric analogue scales (NAS). Results20 pts. were treated by APC and 20 by NK. There were no statistical differences between the 2 groups concerning gender/age or size of the diverticulum (mean size 3.1cm, range 1.2-7.2cm). 3 pts. were excluded from the study (2 pat. died during follow-up due to cardiovascular reasons; 1 pat. was lost to f/u). All of these 3 pts. had been randomized to the APC group. In 2 pts. of the APC group the method had to be changed to NK during therapy, because it was technically impossible to treat these pts. by APC. These cases remained in the original group for analysis. After a mean f/u of 14 months (6-32) 5/17 pts. of the APC group and 3/20 pts. of the NK group were treated more than once (p=0.428; APC-group: 12 pts. with 1 session., 5 pat. with 2 sessions; NK group: 17 pts. with 1, 2 with 2, 1 with 3). Concerning clinical symptoms no statistical significant differences were documented. Both groups of pts. reported of comparable improvements in terms of frequency and intensity of discomfort (qualities: drinking, eating smooth/solid food). We diagnosed 4 complications in the APC-group (23%; 1 emphysema, 3 esophageal stenosis) and 1 complication in the NK group (5%; 1 emphysema). Due to the relatively small sample size the difference was not significant (p=0.159) even if only esophageal stenoses were considered (p=0.23). All complications could be conservatively or endoscopically treated. 3 pat. (each with a minimum of 2 sessions) are still under investigation. Conclusion: Flexible endoscopic mucomyotomy of symptomatic ZD by APC or NK is safe and effective. This randomized controlled trial revealed no significant statistical differences in terms of number of sessions necessary to achieve symptom relief or improvement and complications, respectively. There was a tendency for less sessions necessary for resolution of dysphagia and less complications in the needle-knife-group.
Publication Year: 2009
Publication Date: 2009-04-01
Language: en
Type: article
Indexed In: ['crossref']
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Cited By Count: 1
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