Technology status evaluation report

Devices and techniques for ERCP in the surgically altered GI tract

As the prevalence of obesity continues to rise, increasing numbers of patients undergo bariatric surgery. Management of adverse events of bariatric surgery may be challenging and often requires a multidisciplinary approach. Endoscopic intervention is often the first line of therapy for management of these adverse events. This document reviews technologies and techniques used for endoscopic management of adverse events of bariatric surgery, organized by surgery type.

The MEDLINE database was searched through May 2018 for articles related to endoscopic management of adverse events of bariatric interventions by using relevant keywords such as adverse events related to “gastric bypass,” “sleeve gastrectomy,” “laparoscopic adjustable banding,” and “vertical banded sleeve gastroplasty,” in addition to “endoscopic treatment” and “endoscopic management,” among others. Available data regarding efficacy, safety, and financial considerations are summarized.

Common adverse events of bariatric surgery include anastomotic ulcers, luminal stenoses, fistulae/leaks, and inadequate initial weight loss or weight regain. Devices used for endoscopic management of bariatric surgical adverse events include balloon dilators (hydrostatic, pneumatic), mechanical closure devices (clips, endoscopic suturing system, endoscopic plication platform), luminal stents (covered esophageal stents, lumen-apposing metal stents, plastic stents), and thermal therapy (argon plasma coagulation, needle-knives), among others. Available data, composed mainly of case series and retrospective cohort studies, support the primary role of endoscopic management. Multiple procedures and techniques are often required to achieve clinical success, and existing management algorithms are evolving.

Endoscopy is a less invasive alternative for management of adverse events of bariatric surgery and for revisional procedures. Endoscopic procedures are frequently performed in the context of multidisciplinary management with bariatric surgeons and interventional radiologists. Treatment algorithms and standards of practice for endoscopic management will continue to be refined as new dedicated technology and data emerge.

After more than 15 years since its introduction into clinical practice, indications for device-assisted enteroscopy have greatly expanded. Alongside the consolidated indications such as the diagnosis and treatment of small bowel bleeding, Crohn’s disease, hereditary polyposis, small-bowel tumors and complicated celiac disease, device-assisted enteroscopy is nowadays largely used to perform endoscopic retrograde cholangiopancreatography in patients with altered anatomy, stent placement, retrieval of foreign bodies, direct insertion of jejunal feeding tubes, and in selected cases of incomplete colonoscopy. This has been made possible by the technical improvements of the enteroscopes and accessories and by the widespread use of the method. Device-assisted enteroscopy endotherapy currently offers a safe and effective alternative to major surgery and often represents the preferred option for treatment of small-bowel pathology. Its safety profile is favourable even in the elderly patient, provided that it is performed in high-volume and experienced centers. The evolution of the enteroscopy technique is a challenge for the future and could be facilitated by the new enteroscopes models. These prototypes need a thorough clinical and safety assessment especially for the complex therapeutic procedures. Large prospective, multicenter studies should be performed to assess whether the use of device-assisted enteroscopy leads to improved patients’ long-term outcomes.

The planning required for successful endoscopic retrograde cholangiopancreatography (ERCP) is more complex than that for routine endoscopic procedures and requires the synthesis of multiple variables. Preparation for ERCP involves preparing not just the patient but also the endoscopist, the endoscopy team, the anesthesia team, and the necessary equipment. This chapter will review the most important preprocedure decisions and planning steps when ERCP is being considered, including logistical issues regarding ERCP location and personnel, patient evaluation and preprocedure testing, management of antithrombotic agents, choice of sedation, intraprocedural monitoring, informed consent, antibiotics, and patient positioning. The flow of this chapter will be in a rough chronological order of factors to consider as the procedure draws near.

Endoscopic retrograde cholangiopancreatography (ERCP) is increasingly used as a therapeutic endoscopic technique for managing a range of pancreatic and biliary diseases. Efficacy and safety of ERCP depend on a variety of factors, including an organized and functional ERCP unit. A variety of ancillary devices or accessories and an endoscope are required for therapeutic ERCP. The most commonly used endoscope is the duodenoscope; however, patients with altered anatomy require specialized endoscopes, such as balloon-assisted enteroscopes. Cannulation of the desired duct is key to accomplish successful ERCP. A variety of devices, such as papillotome and cannulation catheters, are available to assist deep cannulation of the desired duct. Therapeutic ERCP requires the availability of a number of stone extraction devices, including stone extraction balloons, baskets, and lithotripsy baskets. Drainage devices such as biliary and pancreatic stents are essential for therapeutic ERCP in treating patients with benign or malignant biliary diseases. Tissue sampling and stricture dilation devices are also available to diagnose and treat biliary obstruction. Recently, single-operator direct visualization of biliary and pancreatic duct has become feasible with new digital cholangioscope. Emerging techniques such as intraductal ultrasound and confocal laser endomicroscopy enable ultrasonic and in vivo histologic assessment of biliary tract via ERCP. Other important issues, including the use of CO₂, fluoroscopy, and radiographic contrast media, as well as the role Food and Drug Administration, are discussed.