The Use of Endoscopic Clipping Devices in the Treatment of Iatrogenic Duodenal Perforation

Over the past 20 years, endoscopic ultrasound (EUS) has evolved from a novel imaging procedure to a clinical diagnostic test that is often essential for optimizing management of gastrointestinal diseases.¹ Currently, 2 different types of EUS systems are available for clinical use: radial and linear. Radial echoendoscopes are particularly useful for examining the esophagus, as they allow a complete circumferential assessment of the esophageal wall layers as well as the lymph nodes and other surrounding structures. Linear echoendoscopes provide a 120-degree ultrasound image parallel to the axis of the endoscope. This linear orientation allows for the passage of a fine aspiration needle through the endoscope's working channel and into targeted tissues.²

EUS is acknowledged to be a safe and tolerable procedure.¹ The complication rate associated with conventional EUS ranges from 0.04% to 0.6%,^3–5 which is similar to the complication rate associated with upper gastrointestinal tract endoscopy (0.1–0.5%).^6,7 A complication rate of 0.12% was reported in a retrospective study of 11,539 EUS examinations; this included a 0.046% complication rate among 10,731 conventional EUS procedures. When a linear probe was used, the complication rate was 0.10% for conventional EUS and 1.11% for interventional EUS, whereas the complication rate for a radial probe was 0.033% for both types of EUS procedures.^1,5 From the above study, it appears that the complication rate associated with linear probes is greater than that associated with radial probes. However, the higher complication rate noted with linear EUS, compared to radial EUS, has not been proven to be statistically significant.¹

EUS-associated complications include infections, bleeding, pancreatitis, perforation, and sedation-related cardiopulmonary events.^1,5 In a prospective study of 1,034 pancreatic EUS–fine-needle aspiration procedures, the rate of overall major complications was 0.29%; this included a rate of 0.96% for hemorrhage, 0.19% for acute pancreatitis, and 0.09% for duodenal perforation.⁸ One of the most fatal complications that has occurred in relation to EUS is perforation.¹ The recognized risk factors connected to duodenal perforation include the lack of a trained endoscopist, the presence of duodenal diverticula, the failure to insufflate the lumen, and the presence of a biliary sphincterotomy.^5,9,10 Seven deaths were reportedly caused by duodenal perforation in a prospective study examining 20,000 EUS procedures that used linear probes.^1,5 Khokhar and colleagues reported a perforation rate of 0.13% among 3,791 EUS procedures.⁵ Based upon other prospective data, a perforation rate of 0.03% has been noted among 400 patients,¹¹ whereas an esophageal perforation rate of 0.04% has been reported in 37,915 EUS examinations, according to retrospective data.³

One of the most common sites for perforation caused by radial probes is the esophagus. By contrast, the duodenum is the most common site for perforation caused by linear probes. However, the occurrence of duodenal perforation with a linear probe is not well defined, due to limited studies.^1,5

The gold standard for treatment of iatrogenic duodenal perforation is surgical repair.^12–14 However, in some cases, conservative medical management may be used for small perforations associated with unconfirmed or small leaks.^12–15 Some physicians utilize surgical repair in all cases of duodenal perforation due to the lower rate of complications associated with early operation.¹⁴ The latest alternative to surgical or medical management of iatrogenic perforation is the endoscopic clipping device. No complications have been recorded to date with the use of this device for closure of iatrogenic perforations. Endoscopic clips were first introduced in 1975 by Hayashi and associates for marking sites for surgical excision and mechanical homeostasis in the gastrointestinal tract.¹⁶ In 1993, endoclips were used for the first time to close an iatrogenic perforation secondary to resection of gastric leiomyoma.¹⁷ Kaneko and colleagues¹⁸ and Roses and associates¹⁹ have used endoclips to treat duodenal perforation secondary to therapeutic endoscopy. Khokhar and coworkers have described 2 patients with iatrogenic duodenal perforation during linear EUS examination who were managed with an endoscopic clipping device.⁵ Furthermore, cases reported by Sebastian and associates,²⁰ Seibert,²¹ and others have demonstrated successful closure of an iatrogenic duodenal perforation with an endoscopic clipping device following EUS examination.^16–18 No complications were reported in these case reports. Complete healing of the perforation site was observed by a 1-month follow-up endoscopy, and the clips were observed to dislodge spontaneously within 3 weeks of placement.

Immediate identification and closure of the perforation is the key to achieving success with endoclips.^5,14 Instant closure of the intestinal tear reduces, in theory, the spread of digestive enzymes, bile, and bacteria to nearby organs. This may result in less inflammation and contamination of bacteria and may enable antibiotics and symptomatic treatment to guard against further morbidity.^5,14

In the above case reports, the intestinal perforation has been closed by endoclips using a through-the-scope system, which has certain limitations. Due to the low closure force and the limited opening distance between the clip jaws, multiple clips are required to close the defect. Moreover, only small defects (10 mm in size) can be closed using the above technique.^22–24 In a recent study, a new over-the-scope clip system (by Ovesco Endoscopy) was used in 10 patients to manage larger leaks (range, 7–20 mm in size) by using only 1 or 2 clips.²² Successful healing of the leaks was accomplished without complications and was confirmed by endoscopy 3 months after treatment.²²

Recent studies recommend the use of an endoclipping device for the management of iatrogenic gastrointestinal perforations in select cases that fulfill the following criteria: instant identification of the perforation during the procedure; a tear that is less than 10 mm in size; an endoscopy team that is experienced with using endoclips; and the availability of surgical help (if necessary).^5,14 After the procedure, the patient should be admitted to the hospital for medical management (including nil-per-os, nasogastric suctioning, and intravenous fluids and antibiotics). Moreover, the patient should be closely monitored for signs of peritonitis, subcutaneous emphysema, hemo-dynamic instability, and sepsis. Imaging studies should be performed 24 hours after the procedure, and a liquid diet may be started if the imaging study does not show any leakage of contrast.⁵

The use of an endoclipping device for the management of iatrogenic duodenal perforation will likely gain in popularity in the near future. Most of the authors mentioned above demonstrated the feasibility of using endoscopic management with an endoscopic clipping device in bowel perforation, though certain limitations still remain. Although there were no complications associated with the use of through-the-scope and over-the-scope systems, more studies are required to confirm the indications and safety associated with them. Moreover, it is still not clear whether the use of such a device is safe in unprepared bowel, and, unfortunately, only smaller perforations with a diameter of 10 mm or less can be closed due to the small size of the endoclips currently available.