Efficacy of Endoscopic Closure of Acute Perforations of the Gastrointestinal Tract

doi:10.1016/j.cgh.2012.02.005

Clinical Gastroenterology and Hepatology

Volume 10, Issue 6, June 2012, Pages 603-608

https://doi.org/10.1016/j.cgh.2012.02.005 Get rights and content

Background & Aims

Acute perforations of the gastrointestinal tract are rare, severe complications of endoscopy that usually require surgical repair. Endoscopic repair of perforations would reduce the need for surgeries; we evaluated the efficacy and safety of endoscopic closure of acute perforations of the gastrointestinal tract by using a new clip device.

Methods

We conducted a prospective, international, multicenter study of 36 consecutive patients (15 male) with acute iatrogenic perforations (5 esophageal, 6 gastric, 12 duodenal, and 13 colonic perforation). Endoscopic repair was performed by using the Over-the-Scope-Clip according to a standardized operating procedure. Primary end point was successful closure, which was determined as endoscopic successful closure without leakage (detected by water-soluble contrast x-ray analysis), and absence of adverse events within 30 days after the procedure.

Results

Immediate closure was endoscopically successful in 33 patients (92%). One patient developed an esophageal perforation while the cap was introduced, and in 2 patients the perforations did not close; these 3 patients were successfully treated with surgery. None of the patients had leakage of soluble contrast on the basis of contrast x-ray. One patient with a closed colonic perforation deteriorated clinically within 6 hours after the procedure. Despite surgery, the patient died within 36 hours. The remaining 32 patients had successful endoluminal closures; the overall success rate was 89% (95% confidence interval, 75%–96%). The mean endoscopic closure time was 5 minutes 44 seconds ± 4 minutes 15 seconds.

Conclusions

The Over-the-Scope-Clip is effective for endoluminal closure of acute iatrogenic perforations. It allows patients to avoid surgery, and 89% of patients had successful closures without adverse events.

Section snippets

Study Design

This is a prospective multicenter cohort study conducted at 11 tertiary care medical centers in Europe. The study was investigator-initiated and investigator-driven and performed in accordance with the principles of the Declaration of Helsinki. The medical ethics committees at each center approved the protocol. Data collection was done by local physicians, who completed online case record forms.

We recruited consecutive patients from April 2009 with documented acute esophageal, gastric,

Baseline Characteristics

Between April 2009 and August 2010 thirty-nine consecutive patients with gastrointestinal perforations were enrolled. Thirty-six patients met inclusion criteria; 2 patients were excluded because the perforations existed over 24 hours at inclusion, and 1 perforation was excluded because it was larger than 3 cm in diameter. Baseline characteristics are summarized in Table 1. Five perforations were located in the esophagus (14%), 6 in the stomach (17%), 12 in the duodenum (33%), and 13 in the

Discussion

This multicenter prospective human trial that was investigating a new endoscopic closure device (OTSC) resulted in a sustained successful endoscopic closure in 89% (32/36) of acute iatrogenic perforations of the gastrointestinal tract. Therefore, the current gold standard for gastrointestinal perforations, could be avoided in 89% of cases. Consequently, general anesthesia, abdominal incisions, temporary ostomies, and their associated morbidity were avoided in these patients. The procedure took

Acknowledgments

Investigators of the CLIPPER Study Group are listed in the Appendix.

Over-the-Scope-Clips and twin graspers were supplied by Ovesco Endoscopy AG, Tübingen, Germany without restrictions.

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Applicability, efficacy, and safety of over-the-scope clips in children
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Over-the-scope clips (OTSCs) are now becoming popular in endoscopy performed in adults for indications such as acute nonvariceal GI bleeding, anastomotic bleeding, and for closure of gastrocutaneous and postgastrostomy fistulae. Varied sizes of clip are available, but even the smallest, 8.5 to 9.8 mm in diameter with its loading device on the tip of the endoscope, increases device and endoscope intubation diameters up to 14.65 mm. This may present challenges in terms of the size of the patient in whom it might be used. OTSCs appear to be effective and safe in the hands of those who are trained appropriately in endoscopy on adult patients; however, the experience of OTSC application in children is not reported. Here we present results of a service evaluation of this technology at 2 regional/national referral pediatric endoscopy units in the United Kingdom and the United States.
Two tertiary centers’ databases were searched to identify cases in which OTSCs were used. Demographics, presentation, anthropometry, comorbidities, efficacy, adverse events, and postprocedure follow-up were recorded, with identification of resolution or recurrence.
OTSC procedures were performed on 24 occasions in 20 patients (11 girls) between February 2018 and February 2021. Patients had a mean age of 12 years (range, 5-17) and a mean weight of 44.42 kg (range, 18.2-70.3). Indications were nonhealing PEG site fistulae (n = 7), acute nonvariceal upper GI bleeding (ANUGIB) from gastric ulcers (5), ANUGIB from duodenal ulcers (3), nonhealing bleeding anastomotic ulcer (3), esophageal mucocutaneous fistula (1), and gastric perforation (1). Technical success was achieved in all but 1 case (95%), and clinical success was achieved in 18 cases (90%).
The OTSC device appears to be effective in children (minimum age 5 years and minimum weight 18 kg) in a limited number of situations including anastomotic ulcer, closure of leaking PEG site, gastric perforation, and bleeding peptic ulcers. The operator should be an experienced endotherapeutic endoscopist with specific OTSC training, and the type and size of the OTSC device should be carefully considered, along with any comorbidities of the patient that may preclude success and/or lead to potential adverse events such as esophageal perforation.
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Over-the-scope clips (OTSCs; Ovesco Endoscopy) have been used for closure of fistulas, leaks, acute perforations, gastrointestinal tract bleeding, and stent anchoring. Adverse events (AEs) include perforation, migration, and ulceration. Little is known about the natural history of OTSCs, and no data addressing the longevity of OTSCs are available. We reviewed our center's experience with the natural history of the OTSC device.
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For all procedures, especially procedures carrying an increased risk for perforation, a thorough discussion between the endoscopist and the patient (preferably together with the patient’s family) should include details of the procedural techniques and risks involved.
The area of perforation should be kept clean to prevent any spillage of gastrointestinal contents into the perforation by aspirating liquids and, if necessary, changing the patient position to bring the perforation into a non-dependent location while minimizing insufflation of carbon dioxide to avoid compartment syndrome.
Use of carbon dioxide for insufflation is encouraged for all endoscopic procedures, especially any endoscopic procedure with increased risk of perforation. If available, carbon dioxide should be used for all endoscopic procedures.
All endoscopists should be aware of the procedures that carry an increased risk for perforation such as any dilation, foreign body removal, any per oral endoscopic myotomy (Zenker’s, esophageal, pyloric), stricture incision, thermal coagulation for hemostasis or tumor ablation, percutaneous endoscopic gastrostomy, ampullectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), endoluminal stenting with self-expanding metal stent (SEMS), full-thickness endoscopic resection, endoscopic retrograde cholangiopancreatography (ERCP) in surgically altered anatomy, endoscopic ultrasound (EUS)-guided biliary and pancreatic access, EUS-guided cystogastrostomy, and endoscopic gastroenterostomy using a lumen apposing metal stent (LAMS).
Urgent surgical consultation should be highly considered in all cases with perforation even when endoscopic repair is technically successful.
For all upper gastrointestinal perforations, the patient should be considered to be admitted for observation, receive intravenous fluids, be kept nothing by mouth, receive broad-spectrum antibiotics (to cover Gram-negative and anaerobic organisms), nasogastric tube (NGT) placement (albeit some exceptions), and surgical consultation.
For upper gastrointestinal tract perforations, a water-soluble upper gastrointestinal series should be considered to confirm the absence of continuing leak at the perforation site before initiating a clear liquid diet.
Endoscopic closure of esophageal perforations should be pursued when feasible, utilizing through-the-scope clips (TTSCs) or over-the-scope clips (OTSCs) for perforations <2 cm and endoscopic suturing for perforations >2 cm, reserving esophageal stenting with SEMS for cases where primary closure is not possible.
Endoscopic closure of gastric perforations should be pursued when feasible, utilizing TTSCs or OTSCs for perforations <2 cm and endoscopic suturing or combination of TTSCs and endoloop for perforations >2 cm.
For large type 1 duodenal perforations (lateral duodenal wall tear >3 cm), being cognizant of the difficulty in closing them endoscopically, urgent surgical consultation should be made while the feasibility of endoscopic closure is assessed.
Because type 2 periampullary (retroperitoneal) perforations are subtle and can be easily missed, the endoscopist should carefully assess the gas pattern on fluoroscopy to avoid delays in treatment and request a computed tomography scan if there is a concern for such a perforation; identified perforations of this type at the time of ERCP may be closed with TTSCs if feasible and/or by placing a fully covered SEMS into the bile duct across the ampulla.
For the management of large duodenal polyps, endoscopic mucosal resection (EMR) should only be performed by experienced endoscopists and endoscopic submucosal dissection (ESD) only by experts because both EMR and ESD in the duodenum require proficiency in resection and mucosal defect closure techniques to manage immediate and/or delayed perforations (caused by the proteolytic enzymes of the pancreas).
Endoscopists should be aware that colon perforations occurring during diagnostic colonoscopy are most commonly located in the sigmoid colon due to direct trauma from forceful advancement of the colonoscope. Such tears recognized at the time of colonoscopy may be closed by TTSCs or OTSCs if the bowel preparation is good and the patient is stable.
Although colon perforation is responsive to various endoscopic tools such as TTSC, OTSC, and endoscopic suturing, perforations in the right colon, especially in the cecum, have been relegated to using only TTSCs because of inability to reach the site of the perforation with an endoscopic suturing device or OTSC if the colon is tortuous or unclean. Recently a new suture-based device for defect closure has been introduced allowing deep submucosal and intramuscular enhanced fixation through a standard gastroscope or colonoscope.
Patients with perforations who are hemodynamically unstable or who have suffered a delayed perforation with peritoneal signs or frank peritonitis should be surgically managed without any attempt at endoscopic closure.
In any adverse event including perforation, it is paramount to ensure accurate documentation, prompt discussion with the patient and family, and swift reporting to the quality officer (or equivalent) and risk management team of the institution (in major adverse events).

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: Conflicts of interest The authors disclose no conflicts.

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Endoscopy cornerEfficacy of Endoscopic Closure of Acute Perforations of the Gastrointestinal Tract

Background & Aims

Methods

Results

Conclusions

Section snippets

Study Design

Baseline Characteristics

Discussion

Acknowledgments

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

J Gastrointest Surg

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Dig Liver Dis

Ann Thorac Surg

Colonoscopic perforations: incidence, management, and outcomes

Am Surg

Treatment of endoscopic esophageal perforation

Surg Endosc

Gastric perforation during endoscopic resection for gastric carcinoma and the risk of peritoneal dissemination

Br J Surg

Surgical management and outcomes of 165 colonoscopic perforations from a single institution

Arch Surg

Endoscopy corner
Efficacy of Endoscopic Closure of Acute Perforations of the Gastrointestinal Tract