Yes, we can: reliable colonic closure with the Padlock-G clip in a
survival porcine study (with video)
Carlos Guarner-Argente, MD, Henry Córdova, MD, Graciela Martínez-Pallí, MD PhD, Ricard Navarro, MD,
Miriam Cuatrecasas, MD PhD, Cristina Rodríguez de Miguel, Mireia Beltrán, Antonio M. Lacy, MD PhD,
Angels Ginès, MD PhD, Maria Pellisé, MD PhD, Josep Llach, MD PhD, Glòria Fernández-Esparrach, MD PhD
Barcelona, Spain
Background: Secure closure of the colonic access site is one of the most important issues for the development
of natural orifice transluminal endoscopic surgery.
Objective: To evaluate the feasibility, reproducibility, and efficacy of a new over-the-scope clip.
Design: Descriptive study, in vivo porcine colon.
Intervention: In 10 female Yorkshire pigs weighing 30 to 35 kg, a 10-mm colotomy was performed by using a
needle-knife and advancing the endoscope to the peritoneal cavity. Colonic closure was performed by using the
Padlock-G clip (Aponos Medical, Kingston, NH) delivered with the Lock-It system (Aponos).
Main Outcome Measurements: Animals were monitored daily for signs of peritonitis and sepsis over a period
of 14 days. During necropsy, the peritoneal cavity was examined, and the colon segment containing the incision
was excised for pathological study.
Results: Closure was achieved in all cases. Nine of 10 pigs survived 14 days without complications, but 1 pig was killed
immediately after the procedure because of severe bleeding during the colonic incision. The median closure time was 8
minutes (range 1-30 minutes). At necropsy, adhesions were observed in 5 cases. The incision was hardly visible at the serosa
side in 3 cases and was not identified in 6 cases. In 6 cases, the clip was still slightly attached to the mucosa, and it was not
found in 3 cases. The pathological study revealed a complete remodeling of the colonic wall in all cases.
Limitations: Animal model, noncomparative study.
Conclusion: The Padlock-G clip procedure is feasible, reproducible, effective, and easy to perform, and it
provides a reliable colonic closure.
Natural orifice transluminal endoscopic surgery holds great
appeal as a less-invasive alternative to laparoscopic surgery.
As natural orifice transluminal endoscopic surgery heads
toward human trials, it is crucial to have a safe, fast, and
reproducible method that allows the performance and clo-
sure of transluminal incisions.
1-3
The colon is a potential
gateway that can be used in the general population, and its
use as a portal may allow better vision and mobility in the
upper abdominal cavity. Several closure techniques have
been tested in the colon, including clips
4-9
and T-tags
10
as
well as more complex suturing devices.
11
However, most of
these devices are time-consuming and often are difficult to
implement endoscopically. Current data do not allow defin-
itive conclusions regarding the different options for this
indication.
The aim of this study was to evaluate the feasibility,
reproducibility, and efficacy of the Padlock-G clip (Apo-
nos Medical, Kingston, NH) for colonic closure in a sur-
vival porcine model.
DISCLOSURE: G.F.-E. had a grant PI08/90026 from the Instituto de Salud
Carlos III. G.F.-E. thanks the Generalitat de Catalunya (AGAUR, BE-
100022) and the Societat Catalana de Digestologia for supporting her
training in NOTES. The authors would like to thank Olympus Medical
Europe (Hamburg, Germany) for providing with the equipment free of
charge for this study. No other financial relationships relevant to this pub-
lication were disclosed.
Copyright © 2010 by the American Society for Gastrointestinal Endoscopy
0016-5107/$36.00
doi:10.1016/j.gie.2010.06.054
Received May 12, 2010. Accepted June 14, 2010.
Current affiliations: Endoscopy Unit (C.G.-A., H.C., C.R.d.M., M.B., A.G., M.P.,
J.L., G.F.-E.), Anesthesiology Department (G.M.-P., R.N.), Pathology
Department, CDB (M.C.), Surgical Department (A.M.L.), Hospital Clinic,
University of Barcelona, IDIBAPS, CIBEREHD, Barcelona, Spain.
Reprint requests: Glòria Fernández-Esparrach, MD, PhD, Endoscopy Unit,
Gastroenterology Department, Hospital Clinic, Villarroel 170, 08036 Barcelona,
Spain.
www.giejournal.org Volume 72, No. 4 : 2010 GASTROINTESTINAL ENDOSCOPY 841