Retrospective Multicenter Analysis of the Technical Success Rate of the Endoscopic Helix Tacking System for Gastrointestinal Defect Closure

Aims A major challenge in interventional endoscopy is the management and treatment of wounds and defects. While prophylactic defect closure plays an important role in reducing the risk of bleeding and secondary perforations, treatment of fistulas and perforation has also remained challenging due to both technical and clinical reasons. Very recently, the Helix Tacking System (X-Tack) received its CE approval for the closure of defects and perforations. The objective of this present study is to evaluate the initial experience with the X-Tack system in three expert centers in Germany.

Methods This was a retrospective multicenter study which included defects treated with X-Tack system from three German endoscopy centers. The primary endpoint of the study was the technical success rate, defined as complete closure of the lesion. Secondary endpoints were clinical success rate and complication rate.

Results Between January and November 2024, 19 patients were treated with the X-Tack system and included in the study. The cases treated included: 4 wound defects after endoscopic mucosal resection (EMR), 5 after endoscopic submucosal dissection (ESD), 1 after endoscopic intermuscular dissection (EID), 1 colocutaneous fistula, 1 esophagotracheal fistula, 1 duodenal fistula, 1 gastric fistula, 1 perforation post-ESD in the stomach, 1 full-thickness resection in the rectum, and 3 rectal stump after Hartmann’s procedure or anastomotic insufficiencies following rectal resection. The technical success rate was 95% (18/19), with a complication rate of 0%. The clinical success rate for post-EMR/ESD defect closure was 100%, while for fistulas and anastomotic/stump insufficiencies, it was 14.2% (1/7).

Conclusions The X-Tack system demonstrates an overall high technical success rate with no complications. However, clinical success depends on lesion selection. Fresh resection defects after EMR or ESD are particularly associated with sustained clinical success. Further prospective data, such as through registry studies, are necessary to better evaluate new closure techniques in the gastrointestinal tract.

Publication History

Article published online:
27 March 2025