Author Affiliations: Division of Gastroenterology, Department of Internal Medicine, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan (Omuta S, Maetani I, Ukita T, Nambu T, Gon K, Shigoka H, Saigusa Y and Saito M)

Corresponding Author: Iruru Maetani, MD, Division of Gastroenterology, Department of Internal Medicine, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan (Tel: 81-3-3468-1251; Fax: 81-3-5465-0210; Email: mtnir50637@med.toho-u.ac.jp)

 

© 2014, Hepatobiliary Pancreat Dis Int. All rights reserved.

doi: 10.1016/S1499-3872(14)60008-4

 

 

Contributors: OS conceived and designed the study, collected, analyzed and interpreted the data, and wrote manuscript; MI edited manuscript and collected the data; UT and SH collected the data; NT, GK, SY and SM treated patients and collected the data. MI is the guarantor.

Funding: None.

Ethical approval: The Institutional Ethical Review Board of Toho University Ohashi Medical Center approved this study, which was conducted in accordance with the Declaration of Helsinki. Written informed consent was first obtained from the patient or a family member.

Competing interest: No benefits in any from have been received or will be received from a commercial party related directly or indirectly to the subject of this article.

 

 

BACKGROUND: The development of direct peroral cholangio­scopy (DPOC) using an ultraslim endoscope simplifies biliary cannulation. The conventional techniques are cumbersome to perform and require advanced skills. The recent introduction of the guidewires and balloons has improved the therapeutic outcomes. Here we describe an effective and easier method for performing DPOC using an ultraslim upper endoscope.

 

METHODS: Indications for DPOC were the presence of stones on follow-up of patients who had previously undergone complete sphincteroplasty, including endoscopic sphincterotomy or endoscopic papillary large balloon dilatation. Fifteen patients underwent DPOC. An ultraslim endoscope was inserted perorally and was advanced into the major papilla. The ampulla of Vater was visualized by retroflexing the endoscope in the distal second portion of the duodenum, and then DPOC was performed using a wire-guided cannulation technique with an anchored intraductal balloon catheter.

 

RESULTS: One patient failed in the treatment due to looping of the endoscope in the fornix of the stomach. Fourteen (93.3%) were successfully treated with our modified DPOC technique. Only one patient (6.7%) experienced an adverse event (pancreatitis) who responded well to conservative management. Residual stones of the common bile duct were completely removed in 3 patients.

 

CONCLUSION: The modified method of DPOC is simple, safe and easy to access the bile duct.

 

(Hepatobiliary Pancreat Dis Int 2014;13:60-64)

 

KEY WORDS: direct peroral cholangioscopy; ultraslim upper endoscope; endoscopic retrograde cholangioscopy; biliary tract

Biliary disease can be diagnosed and treated using conventional peroral cholangioscopy (POC), which allows the operator to directly view the bile duct with a mother-baby endoscopic system. However, this system needs skilled and specifically trained endoscopists to perform the procedure and therefore, limits its wide application. Moreover, the system needs two endoscopists.^[1-6] The fragility and small diameter of the baby scope make the operation more sophisticated.^[2,5] In 2006, Larghi and Waxman reported the feasibility of direct POC (DPOC) using an ultraslim upper endoscope.^[7] Similar procedures and their therapeutic applications have been subsequently reported.^[8-13] Because of the difficulty of accessing the bile duct and lack of skilled operator, however, the success rate was unsatisfactory.^{[7, 8]}

 

Using an intraductal guidance balloon to facilitate the introduction of the endoscope, Moon et al^[11] achieved a success rate of 92.5%. However, this is a sophisticated procedure: a guidewire needs to be introduced into the common bile duct (CBD) via a duodenoscope, which has to be withdrawn while the guidewire is in place, and finally, the ultraslim endoscope is inserted along the guidewire. In the present study, we describe the improvement of the DPOC technique that allows an ultraslim endoscope to be inserted into the duct without a duodenoscope. This modified technique was used to confirm whether residual CBD stones remained in patients who had undergone endoscopic lithotomy. Here, we report the feasibility of this technique for simplifying endoscopic access to the bile duct.

 

 

From November 2008 to December 2010, 15 patients (10 women and 5 men) were prospectively enrolled. Inclusion criteria were as follows: 18 years of age and previous complete sphincteroplasty, including endoscopic sphinc­terotomy (EST) or endoscopic papillary large balloon dilatation (EPLBD). Exclusion criteria were as follows: concomitant stricture of the CBD and post-operative altered anatomy after gastrectomy. DPOC was indicated for complete removal of stones after endoscopic lithotomy in patients with CBD stones or residual CBD stones. The Institutional Ethical Review Board of Toho University Ohashi Medical Center approved this study, which was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from the patients or their family members.

 

DPOC was performed using an ultraslim upper endoscope (GIF-XP260; Olympus, Tokyo, Japan), 5.5 mm outer diameter, 1100 mm working length, and a 2-mm working channel. The balloon catheter included a 4-F sheath and an 11-mm diameter balloon (B5-2Q Olympus). The guidewire was 0.018" in diameter (Roadrunner, Cook Inc., Bloomington, IN, USA).

 

The patients were sedated by intravenous administration of midazolam (5-10 mg) and buprenorphine (0.2 mg). All DPOC procedures were performed by Dr Iruru Maetani, who is highly experienced in endoscopic retrograde cholangiopancreatography (ERCP) and colonoscopy. An ultraslim endoscope was inserted perorally and was advanced into the major papilla using esophago­gastroduodenoscopy (EGD). The ampulla of Vater was visualized by retroflexing the endoscope in the distal second portion of the duodenum. A balloon catheter and a guidewire were first loaded into the working channel of the scope. The endoscope was introduced as follows: First, the balloon catheter was introduced into the bile duct.^[14-16] Second, the guidewire was advanced into the intrahepatic bile duct (IHBD) of the lateral superior segment, if possible. Third, the balloon catheter was advanced into the branch of the duct along the guidewire and was then inflated in the duct. Finally, the endoscope was advanced over the balloon catheter using the ropeway method for traction. The entire procedure was performed under the endoscopic and fluoroscopic control to ensure that the endoscope advanced directly into the major papilla upstream of the bile duct, and the bile duct was irrigated with physiological saline. If necessary, we used only carbon dioxide (CO₂). The stone fragments produced by lithotripsy were captured in a slim basket catheter (FG-18Q-1; Olympus).^[17] The maximum outer diameter of this basket catheter was 1.8 mm and opened width of the basket catheter was 22 mm.

 

The endoscopic and fluoroscopic procedures are shown in Figs. 1-5. The primary endpoint of the present study was to determine the procedural success rate of DPOC in insertion to the biliary system. The secondary endpoint was to determine the incidence of procedure-related adverse events, such as bleeding, perforation, pancreatitis, or cholangitis. Successful DPOC was defined as advancement of the endoscope into the bifurcation of the biliary tree. Sufficient visual examination defined the observation that was detailed from bifurcation to the ampulla of Vater was possible.

 

 The definition of adverse events was based on those listed by Cotton et al.^[18] Data are presented as the median and interquartile ranges (IQRs).

 

 

The success rates and incidence of adverse events for DPOC are summarized in Table. The median age of patients was 81.0 years (IQR: 78.0-88.0), and the median diameter of their CBD stones was 16.0 mm (IQR: 11.0-17.0). DPOC was successful in 14 of the 15 patients (93.3%). Visual examinations revealed that the endoscope was successfully inserted in all patients (14/14; 100%); however, we were unable to advance endoscope into the bile duct in one patient because of looping of the endoscope in the fornix of the stomach. Of the 15 patients enrolled, 13 had undergone EST and two had undergone EST and EPLBD. The median time for introduction of endoscope into the CBD was 14.5 minutes (IQR: 7.5-21.0) in the 14 patients. Pancreatitis in one patient represented the only procedure-related adverse event (1/15, 6.7%), and it was treated conservatively. The severity grade was mild according to the definition of adverse events.^[18] Because spontaneous hemostasis was achieved during the procedure, bleeding (Mallory-Weiss syndrome) was classified as an adverse event.^[18] Pancreatitis and bleeding (Mallory-Weiss syndrome) developed in the same patient.

 

 

In 2006, DPOC with an ultraslim upper endoscope, which was originally designed for transnasal EGD, was first proposed as a tool for direct visual examination of the biliary tree during diagnostic procedures.^[7] Moreover, the authors of that study reported that the procedure could be performed by one physician using a single endoscope and few instruments. An ultraslim endoscope provides almost the same image quality as a standard gastroscope. Separate water and air channels facilitate intraductal visualization and do not require external water pumps. Moreover, the working channel is large enough for performing certain therapeutic procedures. Larghi and Waxman reported the promising results of ERCP using an ultraslim upper endoscope that was introduced into the biliary system via a guidewire. However, they reported only 3 patients.^[7]

 

Park et al^[8] applied pressure to the patient's abdomen to facilitate advancing an ultraslim endoscope into the biliary system to prevent loop formation of the endoscope in the stomach; however, the use of this technique in other patients was not described. Choi et al^[10] evaluated the effectiveness of a balloon-mounted overtube to maintain access to the biliary system in DPOC when an ultraslim endoscope was used. A balloon-mounted overtube is considered useful in DPOC; but the diameter of the available overtube is too large for an ultraslim endoscope, thus making it difficult to manipulate both the overtube and the endoscope.

 

The SpyGlass® single-operator cholangiopancreato­scopy system (Boston Scientific Co., Natick, MA, USA) might simplify the performance of POC but the visual findings remain difficult to interpret.^[19] Pohl et al^[20] evaluated the feasibility of using an intraductal balloon to maintain access without prior placement of a guidewire. The procedural success rate of this method was only 72%. In contrast, Moon et al^[11] reported a success rate of 92.5% for introducing an endoscope into the duct. In that procedure, the wire is backloaded into the ultraslim scope through a balloon catheter after removal of the duodenoscope.^[11]

 

Our method is a modified version from Moon and colleagues.^[11] The method makes it possible to introduce the ultraslim endoscope into the duct without using a duodenoscope. Another advantage is that we advanced the endoscope into the bile duct and therefore the ampulla of Vater was endoscopically visualized by retroflexing the endoscope in the distal second portion of the duodenum. The difficulties associated with DPOC reported by Moon et al^[11] were caused by the relatively acute angle between the second part of the duodenum and the biliary system and the looping of the endoscope in the stomach. We suppose that the endoscope is more maneuverable, when it was retroflexed in the second part of the duodenum because of the eliminated acute angle between the second part of the duodenum and biliary system, to decrease the loop which enabled the insertion of a catheter into the biliary system under direct visualization without a duodenoscope.^{[21, 22]}

 

After the successful insertion of a balloon catheter and a guidewire into the biliary system, they were advanced into the IHBD. A balloon placed in the superior segment facilitated the upstream advancement of the endoscope. In one case, we failed to advance the endoscope into the bile duct and experienced looping of the endoscope in the fornix of the stomach because of a waterfall stomach. The ampulla of Vater could not be endoscopically visualized by retroflexing the endoscope in the distal second portion of the duodenum. The median cannulation time was 14.5 minutes (IQR: 7.5-21.0) in our 14 successful cases. Choi et al^[10] reported that the time required for biliary cannulation was 12.6 minutes. In our series, patients 1-7 required a median of 21.0 minutes for cannulation, whereas patients 8-15, which are more recent, required a median of only 7.5 minutes. The more cases we experienced, the faster the endoscope was inserted into the CBD to achieve a procedural success. We performed successful lithotomy in 3 patients (3/3; 100%) with residual CBD stones. Lee et al^[23] performed lithotomy with the same procedure. But they failed to remove residual stones in two patients, because removal of the intraductal balloon catheter led to the instable position of the endoscope. However, we did not experience this situation because the ampulla of Vater was visualized by retroflexing the endoscope which facilitates the insertion of endoscope to the biliary system.

 

 The present study has some limitations. The study was conducted at a single institution with a small sample size and lack of a control group. To objectively evaluate the performance of the modified procedure, its outcomes should be compared with those of conventional cholangioscopy.

 

In conclusion, our DPOC technique does not require a duodenoscope. It is safe, simple and therefore easier to perform as compared with conventional POC. DPOC using an ultraslim endoscope is useful for the diagnosis and treatment of patients who have received endoscopic lithotomy to treat choledocholithiasis. The success of our procedure warrants a large scale study to more objectively evaluate its feasibility.

 

 

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