Hydrogen leak test is minimally invasive and highly specific for assessment of the integrity of the luminal closure after natural orifice transluminal endoscopic surgery procedures (with video)
Background
Leak-resistant closure of transluminal access is a major challenge facing natural orifice transluminal endoscopic surgery (NOTES).
Objective
To evaluate a hydrogen (H2)-based leak test for assessment of transluminal-access closure integrity after NOTES procedures.
Setting
Nine acute porcine experiments.
Design and Intervention
After gastric-wall puncture and balloon dilation, peritoneoscopy was performed, followed by transmural closure of the gastric opening. The animals were randomly assigned to complete or incomplete closure groups. The H2 leak test was performed by using 1000 mL of 4% H2 gas mixture and the Hydrogen Leak Detector H2000+. The animals were then euthanized for a methylene blue (MB) test of gastric closure integrity.
Main Outcome Measurement
Intraperitoneal H2 concentration after gastric insufflation with H2.
Results
The H2 leak test was quick and easy. Intraperitoneal H2 concentrations in parts per million in both groups were similar at baseline (mean ± SD, 0.18 ± 0.29 parts per million [ppm] vs 0.22 ± 0.35 ppm, P = .97) and after balloon dilation (414.8 ± 198.5 ppm vs 601.3 ± 116.1 ppm, P > .99). Postclosure intraperitoneal H2 concentrations dropped to 0.01 ± 0.77 ppm in the complete-closure group, similar (P = .81) to matched-pairs preopening levels and significantly lower than in the incomplete-closure group (162.0 ± 83.0 ppm, P < .02). On necropsy, the MB test was negative in all 5 animals of the complete-closure group and positive in all 4 animals of the incomplete-closure group. A cutoff of 25 ppm in intraperitoneal H2 concentration after closure gave 100% sensitivity, specificity, and positive and negative predictive values for MB leakage.
Limitations
Nonsurvival animal experiments.
Conclusions
The H2 leak test is highly accurate for detection of leakage after NOTES procedures and could become a substitute for currently used MB leak tests.
Abbreviations: CO2, carbon dioxide, H2, hydrogen, IRB, institutional review board, ISO, International Organization for Standardization, MB, methylene blue, NOTES, natural orifice transluminal endoscopic surgery, ppm, parts per million
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DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: S. V. Kantsevoy and A. N. Kalloo are equity holders in Apollo Endosurgery Inc, Austin, Tex. All other authors disclosed no financial relationships relevant to this publication. This research was not sponsored by any company and was conducted by using internal funds of Division of Gastroenterology, Johns Hopkins University School of Medicine. T-bars for use during this study were provided free of charge by Cook Endoscopy. The overtubes for this study were provided free of charge by Apollo Endosurgery. Hydrogen Leak Detector H2000+ was provided free of charge by Alcatel Vacuum Products.
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PII: S0016-5107(08)02678-3
doi:10.1016/j.gie.2008.09.053
© 2009 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
