ERCP with single-use disposable duodenoscopes in four different set-ups

Abstract

Endoscopic retrograde cholangiopancreatography (ERCP) has until now always been performed using a reusable non-sterile duodenoscope. The introduction of the new single-use disposable duodenoscope makes it possible to perform perioperative transgastric and rendezvous ERCP in an almost sterile manner. It also eliminates the risk of patient-to-patient transmission of infection in non-sterile settings. We present four patients who underwent different types of ERCP using a sterile single-use duodenoscope. This case report aims to demonstrate the use and the many potential advantages of the new disposable single-use duodenoscope in both sterile and non-sterile settings.

Background

Endoscopic retrograde cholangiopancreatography (ERCP) is an interventional procedure performed using a duodenoscope, generally non-sterile. Growth of biofilm is common in the biopsy channels and in the water–air channels,¹ and the duodenoscope has a more complex structure than a conventional gastrointestinal endoscope, making it more difficult to clean. This can lead to the spread of infectious organisms from patient to patient regardless of the setting.² When performing a laparoscopically assisted transgastric ERCP, the operational field needs to be redraped before and after using the non-sterile reusable duodenoscope. It is now possible to avoid these problems with the introduction of the new sterile single-use disposable duodenoscopes. Currently, there are only two companies that produce this type of duodenoscope: Boston Scientific and Ambu. We have evaluated the single-use duodenoscope (EXALT Model D) from Boston Scientific.

Case presentation

Using the single-use disposable duodenoscope from Boston Scientific (figure 1), 10 ERCPs were successfully performed at a university hospital. We report four of these cases: one regular ERCP, one ERCP with SpyGlass, one perioperative rendezvous ERCP and one transgastric ERCP.

Figure 1.

The sterile single-use duodenoscope before it is unpacked.

In all four cases, the indication for ERCP was complicated gallstone disease. All procedures were performed by expert endoscopists, each with a minimum of 100 ERCP procedures performed per year. All patients were under general anaesthesia during the procedure, and all procedures were made in the same setting in the operating room. Afterwards, the procedures were evaluated by the endoscopist using the same performance characteristics scheme as used in previous reports,^{3 4} making it easier to compare the single-use duodenoscope with the reusable duodenoscope.

Patient 1

A woman in her 70s with a history of breast cancer, but no systemic diseases, had been admitted to the surgical department multiple times due to complicated gallstone disease. She had undergone a laparoscopic cholecystectomy 1 year prior and several ERCPs due to multiple stones in the deep bile ducts. It was not possible to remove the last stone due to its size and the patient therefore underwent an ERCP with SpyGlass-guided electrohydraulic lithotripsy. It was uncertain whether all fragments were removed and therefore a stent was placed. She was scheduled for a new ERCP with stent removal a few months later.

In January 2021, she was admitted for the elective procedure. She had a preoperative American Society of Anesthesiologists (ASA) score of 2 and a performance status (PS) of 0. The sterile single-use duodenoscope was used for the ERCP. The stent was successfully removed and there were no remaining stones in the deep gall ducts. The patient was discharged later on the same day without any complaints and has not been admitted since.

Patient 2

A woman in her late 50s with hypertension, type 2 diabetes and chronic kidney disease with unilateral nephrostomy had a history of complicated gallstone disease with stones in the deep bile ducts. Additionally, she had an ileostomy after a total colectomy 30 years ago, and was known to have familial adenomatous polyposis. She had undergone open cholecystectomy 4 months prior and multiple ERCPs in the past. She was scheduled for an ERCP with single-use duodenoscope and SpyGlass in March 2021 (figure 2).

Figure 2.

SpyGlass cholangioscope with the single-use duodenoscope. Fragmenting gallstone in the common bile duct with electrohydraulic lithotripsy.

She had a preoperative ASA score of 3 and a PS of 0. The procedure was uneventful. The old stent was removed and the gallstones were fragmented. A new stent was placed in the ductus hepaticus communis due to the many fragments. She was discharged later on the same day, and a subsequent elective ERCP with stent removal and further duct clearance was planned.

Patient 3

A man in his late 20s with Arnold-Chiari syndrome including myelomeningocele and late-stage amyotrophic lateral sclerosis needed urgent endoscopic intervention due to complications after cholecystectomy in June 2021. He had been medically treated with intravenous antibiotics for acute cholecystitis a couple of times. Surgery had previously been avoided due to the high risk of complications but now considered unavoidable due to lack of remission. He had an ASA score of 4 and a PS of 4 but was fully able to give informed consent. A laparoscopic cholecystectomy was performed. The gallbladder was removed, but unfortunately an iatrogenic lesion of the ductus cysticus occurred during the dissection. A perioperative peroral ERCP with a reusable duodenoscope was attempted, but it was not possible to get passed the narrow oesophagus due to malformation of the neck. As a damage control intervention, a surgical drain was placed in the surgical site by the bile duct to relieve any upcoming cholascos. The following day, he was planned for a transgastric ERCP with the necessary surgical expertise.

Due to his condition with narrowing in the upper gastrointestinal tract, a transgastric ERCP was planned (figure 3). The sterile duodenoscope was inserted into the abdomen through a 15 mm port, and assisted by the primary surgeon it was further inserted to the ventricle, through the duodenum and into the deep bile ducts, where two stents were successfully placed.

Figure 3.

Transgastric endoscopic retrograde cholangiopancreatography performed using the single-use duodenoscope in a sterile setting.

He was discharged on postoperative day 9 in his habitual condition. He was scheduled for a laparoscopic transgastric endoscopy 3 months later and both stents were removed.

Patient 4

A man in his 60s with hypertension and a history of both STEMI and non-STEMI was admitted to the surgical department with acute gallstone pancreatitis in July 2021. Gallstones in the gallbladder were verified on both ultrasound and magnetic resonance cholangiopancreatography (MRCP). The choledochal duct was dilated on ultrasound. There was no evidence of stones in the deep bile ducts on MRCP, but the alanine transaminase and bilirubin levels were high.

The patient had an ASA score of 3 and a PS of 1. Laparoscopic cholecystectomy with perioperative cholangiography was planned during the same admission. The cholangiography showed a contrast defect, and it was decided to go through with a rendezvous ERCP (figure 4). During the procedure, it was found that the papilla of Vater was frayed, probably due to a passed gallstone. There was also benign stenosis of the deep bile ducts. Therefore, a stent was placed in the choledochal duct. He was discharged 2 days after the procedure and had the stent removed a couple of months later as planned. The patient has reported that he has been asymptomatic since the first ERCP.

Figure 4.

Rendezvous endoscopic retrograde cholangiopancreatography performed using the single-use duodenoscope.

Outcome and follow-up

Three of four patients were discharged after the predicted time. One of the patients required prolonged admission due to his severe habitual condition. No perioperative or postoperative complications were reported, and none of the patients was readmitted due to complications or insufficient treatment. Out of the 10 procedures, 7 were rated using the same scoring scale (table 1).

Table 1.

Ratings on 23 ERCP performance characteristics (n=7)

Performance characteristics	Mean rating
Ease and ability to intubate the oesophagus	4.8
Ease and ability of traversing the stomach and pylorus	5
Inadvertent slippage out of the duodenum	4.8
Navigation/pushability (overall from insertion to the deepest point of advancement into the duodenum)	4.9
Predictability of range of motion	4.9
Suction performance	4.3
Ability to select short/long position as needed	4.6
Ease and ability to examine luminal mucosa where necessary	4.7
Stability of scope during cannulation of papilla	4.7
Elevator function	4.4
Ability to selectively cannulate	5
Tip control and deflection at time of cannulation	4.9
Ease of controlling and maintaining position during sphincterotomy	4.9
Position of the device in the field of view	5
Visualisation/location of important landmarks on monitor	5
Maintenance of grip on wire by elevator	4.7
Elevator strength and ability to pass rigid device into common bile duct or pancreatic duct	4.7
Torquability of scope and ability to orient the tip of the scope in the direction of push/pull	4.7
Ease and ability of passing ancillary devices through the channel of the single-use duodenoscope	4.9
Ease and ability of advancing ancillary devices from the channel of the single-use duodenoscope into the papilla	4.7
Ease and ability to complete all ERCP-guided tasks	4.9
Ease and ability of duodenoscope withdrawal	5
Image quality/appearance/brightness	4.3

Rating from 1: not preferred to 5: comparable with the endoscopist’s usual reusable duodenoscope.

ERCP, endoscopic retrograde cholangiopancreatography.

All endoscopists reported that the single-use duodenoscope was easy to use in the different set-ups described in the cases.

Discussion

A recent report found that the single-use duodenoscope is comparable with a reusable duodenoscope when ERCPs were performed by expert endoscopists.³ This is consistent with our findings. The same results have also been reported for endoscopists with varying ERCP experience.⁴ Serious duodenoscope-associated infections with multidrug-resistant bacteria are rare but documented internationally.^{4 5} The single-use duodenoscope could be a favourable alternative when it is crucial to minimise the risk of contamination in non-sterile settings,⁵ for example when performing an ERCP on a patient with compromised immunological functions⁶ or during a pandemic. The introduction of the new duodenoscope makes it possible to perform a perioperative ERCP without breaking sterility during the procedure.⁷ Single-use scopes are also more mobile than reusable scopes, making it possible to perform some endoscopic procedures without first moving the patient to the endoscopy unit or the operating room. With these scopes, there is also no need for reprocessing and repairs. Single-use endoscopes open new prospects for the future.

Learning points.

• The introduction of the new sterile duodenoscope makes it possible to eliminate the risk of transmitting diseases from one patient to another through the duodenoscope.

• The single-use disposable duodenoscope may be feasible in both sterile and non-sterile settings and matches the reusable duodenoscope without compromising the safety of the patients.

• The sterile duodenoscope does not need to be cleaned or reprocessed, making it less time-consuming and more price-transparent.

• With the benefits of the sterile duodenoscope compared with the standard of care with negligible drawbacks, it should be considered an alternative for endoscopic retrograde cholangiopancreatography in some settings.

Ethics statements

Patient consent for publication

Obtained.