VANCOUVER, B.C.—Two commonly employed devices for closing large defects in gastric mucosa performed well but differently in a randomized controlled trial, suggesting both have their own role in advanced endoscopy.
One of the devices, the dual action tissue clip (DAT, Micro-Tech Endoscopy), may be a better choice for more situations, but the other, the tack/suture device X-Tack (Apollo Endosurgery), may be more effective for duodenal defects, according to the research.
The tissue clip “device is faster and likely more cost effective, but the [tack/suture device] is likely a better option for resection beds more than 50% of the circumference and for defects located in the duodenum,” reported lead researcher Salmaan A. Jawaid, MD, an assistant professor of gastroenterology at Baylor College of Medicine, in Houston.
The dual action tissue clip and tack/suture devices are through-the-scope tissue approximation devices. The tissue clip device employs standard through-the-scope clips, whereas the tack/suture device employs tacks tethered by sutures. The devices are employed in the first of a two-step process to appose healthy mucosa from the resection edges so they can be rejoined by clips or tacks. Once the edges are attached, closure of the remaining bed becomes easier, particularly for large defects.
The concept of a two-step process is not new but is becoming more standardized now that larger mucosal defects are being created with more advanced procedures, Dr. Jawaid said.
In the trial, which aimed to determine whether one device was better than the other, Dr. Jawaid and his co-investigators randomized patients with large resection defects, defined as more than 20 mm in width and more than 30 mm in length, to undergo closures initiated with one of the two devices. The study, which was presented at the Presidential Plenary session at the 2023 annual meeting of the American College of Gastroenterology (abstract 8), lasted about nine months and enrolled 56 patients. The primary outcomes were technical success and costs. Secondary end points included speed and safety.
Approximately 85% of the defects in the 25 patients randomized to dual action tissue clip involved the colon or rectum, and the remaining four (16%) involved the duodenum. For the 31 patients randomized to the tack/suture device, repair of defects in the colon or rectum accounted for most of the procedures, but two involved the stomach and two the duodenum.
The average resection size was approximately 1,200 mm2 in both groups. The rate of complete tissue approximation was 83.9% for the tissue clip device and 88% for the tack/suture device (P=0.92). The rates of closure were 93.5% and 92% (P=0.83), respectively.
The tack/suture device required a greater approximation time compared with the tissue clip device (12.2 vs. four minutes; P<0.0001). Based on time, the average costs of approximation ($974 vs. $673; P=0.002) and average cost of complete closure ($1,578 vs. $1,112; P=0.003) were both higher with the tack/suture device. However, the total procedure time—although numerically longer with the tack/suture device—was not significantly different (103 vs. 98 minutes; P=0.06).
For defects in the duodenum, the tack/suture device was more effective, resulting in approximation of the defect in all cases, versus none with the tissue clip device. The tack/suture device also was more effective for resection beds involving more than 50% of the circumference.
In a detailed analysis of tissue clip device failures, two of the five involved tissue tearing during approximation. A third, which involved a case with a resection bed size of 2,000 m2, was related to an inability to grasp and approximate the two edges. Two failures were in the duodenum, one was in the stomach and two were in the lower intestine.
Of the three tack/suture device failures, all in the lower intestine, one involved a device malfunction, another involved a suture breakage and a third involved difficulty maneuvering the endoscope.
Three of the five tissue clip failures were closed with the tack/suture device, while one of the tack/suture device failures was successfully closed with the tissue clip device.
There were two device-related adverse events with the tissue clip device versus one with the tack/suture device (P=0.20). Post-electrocautery syndrome was observed in three of the tack/suture device patients versus two of the tissue clip device patients (P=0.73). There were no delayed perforations in either arm. Delayed bleeding occurred in two patients in each arm (P=0.61).
‘Welcome Additions’ to the Toolbox
These data are useful and timely, according to Seth A. Gross, MD, the clinical chief of the Division of Gastroenterology and Hepatology at NYU Langone Health, in New York City.
“As endoscopic resection defects get larger as more endoscopists offer endoscopic mucosal dissection, hybrid endoscopic mucosal dissection and endoscopic mucosal resection, conventional clips are often not able to close these defects,” Dr. Gross told Gastroenterology & Endoscopy News.
While this randomized controlled trial addresses the merits of “a new category of devices to close large defects,” Dr. Gross predicted that the adoption by endoscopists will be driven by “ease of use and cost.” Still, he said, based on his own experience and the new evidence that both of the tested devices are effective, “these are welcomed additions to the endoscopic toolbox.”
—Ted Bosworth
Dr. Gross reported financial relationships with Cook, Medtronic, Microtech, Neptune and Olympus. Dr. Jawaid reported financial relationships with Boston Scientific, ConMed, Creo Medical and DiLumen.
This article is from the December 2023 print issue.