Indication for 'Over the scope' (OTS)-clip vs. covered self-expanding metal stent (cSEMS) is unequal in upper gastrointestinal leakage: results from a retrospective head-to-head comparison

Abstract

Background: Intestinal perforation or leakage increases morbidity and mortality of surgical and endoscopic interventions. We identified criteria for use of full-covered, extractable self-expanding metal stents (cSEMS) vs. 'Over the scope'-clips (OTSC) for leak closure.

Methods: Patients who underwent endoscopic treatment for postoperative leakage, endoscopic perforation, or spontaneous rupture of the upper gastrointestinal tract between 2006 and 2013 were identified at four tertiary endoscopic centers. Technical success, outcome (e.g. duration of hospitalization, in-hospital mortality), and complications were assessed and analyzed with respect to etiology, size and location of leakage.

Results: Of 106 patients (male: 75 (71%), female: 31 (29%); age (mean ± SD): 62.5 ± 1.3 years, 72 (69%) were treated by cSEMS and 34 (31%) by OTSC. For cSEMS vs. OTSC, mean treatment duration was 41.1 vs. 25 days, p<0.001, leakage size 10 (1-50) vs. 5 (1-30) mm (median (range)), and complications were observed in 68% vs. 8.8%, p<0.001, respectively. Clinical success for primary interventional treatment was observed in 29/72 (40%) vs. 24/34 (70%, p = 0.006), and clinical success at the end of follow-up was 46/72 (64%) vs. 29/34 (85%) for patients treated by cSEMS vs. OTSC; p = 0.04.

Conclusion: OTSC is preferred in small-sized lesions and in perforation caused by endoscopic interventions, cSEMS in patients with concomitant local infection or abscess. cSEMS is associated with a higher frequency of complications. Therefore, OTSC might be preferred if technically feasible. Indication criteria for cSEMS vs. OTSC vary and might impede design of randomized studies.

Fig 1. Workflow of the treatment of patients with upper gastrointestinal leakage.

Success—clinical success defined as demission from the hospital with resolution of symptoms that had been caused by the leakage; sponge—endoscopic vacuum therapy; *success: n = 5, death: n = 5, success by further treatment: n = 4; **success: n = 1.

Fig 2. Kaplan-Meier curve with calculated actuarial event free survival probabilities after the first session of endoscopic therapy for the cSEMS group (solid line) and OTSC group (scattered line).