Novel endoscopic over-the-scope clip system

Abstract

This paper reports our experience with a new over-the-scope clip in the setting of recurrent bleeding and oesophageal fistula. We treated five patients with the over-the-scope Padlock Clip™. It is a nitinol ring, with six inner needles preassembled on an applicator cap, thumb press displaced by the Lock-It™ delivery system. The trigger wire is located alongside the shaft of the endoscope, and does not require the working channel. Three patients had recurrent bleeding lesions (bleeding rectal ulcer, post polypectomy delayed bleeding and duodenal Dieulafoy’s lesion) and two patients had a persistent respiratory-esophageal fistula. In all patients a previous endoscopic attempt with standard techniques had been useless. All procedures were conducted under conscious sedation but for one patient that required general anaesthesia due to multiple comorbidities. We used one Padlock Clip™ for each patient in a single session. Simple suction was enough in all of our patients to obtain tissue adhesion to the instrument tip. A remarkably short application time was recorded for all cases (mean duration of the procedure: 8 min). We obtained technical and immediate clinical success for every patient. No major immediate, early or late (within 24 h, 7 d or 4 wk) adverse events were observed, over follow-up durations lasting a mean of 109.4 d. One patient, treated for duodenal bulb bleeding from a Dieulafoy's lesion, developed signs of mild pancreatitis 24 h after the procedure. The new over-the-scope Padlock Clip™ seems to be simple to use and effective in different clinical settings, particularly in “difficult” scenarios, like recurrent bleeding and respiratory-oesophageal fistulas.

Keywords: Therapeutic endoscopy, Over-the-scope clip, Non variceal gastrointestinal bleeding, Endoscopic hemostasis, Respiratory-oesophageal fistula, Fistula closure

Core tip: We report our experience with the novel over-the-scope Padlock Clip™, applied in five patients in the clinical settings of oesophageal fistulas and refractory gastrointestinal bleeding. The Padlock Clip^TM has shown reliable closure of wall defects in a porcine survival study, although clinical usage remains limited. As yet, there are no published data regarding its application in the management of non-variceal gastrointestinal bleeding. We provide a comprehensive iconographic documentation and two videos showing its application. We also accurately describe the device and its release system, pointing out the differences with the well-known over-the-scope clip system.