CHOLANGIOSCOPY IN BILE DUCT DISEASE: a case series

Colangioscopia nas afecções biliares: uma série de casos

Abstracts

Context  Direct endoscopic visualization of biliopancreatic duct is certainly one of the greatest advances of therapeutic endoscopy. The use of a single-operator cholangioscopy platform (SpyGlass) is a promising technique in the evaluation of diseases such as indeterminate biliary stricture and giant choledocholitiasis. This is the first Brazilian case series using this technology.

Methods  We report a case series of 20 patients in whom SpyGlass was used with diagnostic and therapeutic intention.

Results  Most patients were female (60%) and the median age was 48 years (ranging from 14 to 94). Choledocholitiasis was the most common indication (12/20), and electrohydraulic lithotripsy was applied in eight (66%). Electrohydraulic lithotripsy was successful in seven (87.5%) patients. Partial stone fragmentation occurred in one patient with large stone causing stone-choledochal disproportion, which was conducted with biliary plastic stent placement and a second scheduled endoscopic approach in 3 months. In cases of undefined etiology of biliary strictures, it was possible to exclude malignancy due to direct visualization (7/8) or biopsy (1/8). One complication occurred (duodenal perforation) after papillary balloon dilation.

Conclusion  The use of SpyGlass demonstrated the benefits, especially in cases of large bile duct stones and indeterminate biliary strictures. Other potencial improvements such as reduction on radiation exposure should be confirmed in prospective studies.

Cholangiography, utilization; Lithotripsy; Choledocholithiasis; Gallstones

Contexto  A visão endoscópica direta das vias biliopancreáticas é certamente um dos maiores avanços na endoscopia terapêutica. O uso da plataforma de colangioscopia de operador-único (SpyGlass) é uma técnica promissora na avaliação de afecções tais como estenoses de etiologia indefinida e coledocolitíase gigante. Essa é a primeira série de casos brasileira utilizando o método.

Métodos  Reportamos uma série de casos de 20 pacientes nos quais foi realizado Spyglass com objetivos diagnósticos e terapêuticos.

Resultados  A maioria dos pacientes era do sexo feminino (60%), com idade que variou de 14 a 94 anos (mediana de 48). Coledocolitíase foi a indicação mais comum (12/20) e litotripsia eletrohidráulica foi realizada em oito (66%). Litotripsia eletrohidráulica foi realizada com sucesso em sete (87,5%) pacientes. Fragmentação parcial dos cálculos ocorreu em um paciente com desproporção cálculo-coledociana, sendo conduzido com colocação de prótese plástica e reabordagem endoscópica programada em 3 meses. Nos casos de estenoses biliares de etiologia indeterminada, foi possível a exclusão de malignidade devido a visualização direta (7/8) ou biópsia (1/8). Uma complicação ocorreu (perfuração duodenal) após dilatação balonada da papila.

Conclusão  Foram demonstrados os benefícios do uso do Spyglass, principalmente nos casos de coledocolitíase gigante e estenoses biliares de etiologia indefinida. Outras potenciais vantagens como a redução da exposição à radiação deve ser confirmada em estudos prospectivos posteriores.

Colangiografia, utilização; Litotripsia; Coledocolitíase; Cálculos biliares

INTRODUCTION

In the last decades, endoscopic retrograde cholangiopancreatography (ERCP) has improved on diagnosis and treatment of biliary diseases, with over 90% success rates^{(7, 16, 17)}. However, despite ERCP being considered the gold standard for diagnosis of common bile duct (CBD) stones, there is 8%-16% of false negative cholangiography⁽¹⁶⁾. Some conditions such as large bile duct stones(>15 mm) and biliary strictures of undetermined cause remain challenging. Even with technological advances in imaging methods, differential diagnosis between benign and malignant biliary strictures may remain unclear in 50% of the cases^{(7, 12)}.

In this scenario, “mother-baby scope” cholangioscopy was introduced in 1975 The aim was to overcome diagnostic limitations of biliary diseases, allowing direct visualization of bile ducts^{(7, 12)}. Although available for more than three decades, its use remained restrict mostly due to high cost method, and the need of two experienced endoscopists during the same procedure^{(1, 2 ,11, 12)}.

In 2006, a new single-operator cholangioscopy platform (SpyGlass) was developed (Figure 1). It allowed direct view biopsies and lithotripsy to become a more effective and feasible procedures⁽⁷⁾. As a consequence of its numerous advantages, the use of SpyGlass became widespread, currently being used by over 800 endoscopists worldwide with more than 35000 procedures performed⁽¹⁶⁾.

FIGURE 1.
Spyglass^TM. Single operator cholangioscopy plataform

The combination between SpyGlass and electrohydraulic lithotripsy (EHL), which was usually used by urologists, allowed treatment of choledocholitiasis through specific biliary catheters by stone fragmentation under direct view and subsequent fragments removal.

In a study published by Chen et al.⁽²⁾, success rate of cholangioscopy feasibility with SpyGlass was 89%. Other studies demonstrate a rate of success up to 97%, and in cases of undefined etiology biliary stricture important information were added^{(1, 2, 11, 12, 13)}.

METHODS

This is a prospective study of 20 consecutive and not randomized patients. Inclusion criteria were undefined bile duct strictures and large CBD stones that were difficult to be removed by ERCP (Figure 2).

FIGURE 2.
Giant bile duct stone. A: Radiologic view; B: Direct view

All procedures were performed by two experienced endoscopists (EGHM and TF), using a therapeutic duodenoscope (ED-250XT5; Fujinon). Forceps biopsies (Spybite) of the specimens were taken under direct visualization. A force generator Nortech autolith^® (Northgate Technologies, Inc, Elgin, Ill) and a 1.9 F probe lithotriptor device were used in patients undergoing electrohydraulic lithotripsy, with an initial setting of 5 pulses per second and 50 W of power and, if necessary, gradually increases up to 10 pulses per second and 100W of power. Success rate of EHL procedure was considered when a large stone was fragmented and removed from CBD.

Antibiotic, Ciprofloxacin 400 mg IV, was given as prophylaxis. The procedure was performed under conscious sedation using a combination of fentanyl, midazolam and propofol.

Patients were submitted to conventional ERCP with CBD cannulation using a guidewire. Cholangiography was obtained after contrast media injection. Sphincterotomy was performed in all cases, nine of these in the same procedure and eleven had it previously done (Figure 3). Seven patients underwent balloon dilation of the major papilla, ranging from 10 to 15 mm, according to stone size and distal bile duct diameter. After this analysis, cholangioscopy was performed and the specific treatment was instituted for each case.

FIGURE 3.
Patient's demographic, SpyGlass indications, ERCP and SpyGlass procedures

Sex F: female; Sex M: male

In cases of giant CBD stones (Figure 2), it was created a liquid interface by flushing a 0.9% saline solution through an irrigating pump connected to SpyGlass system. After stone fragmentation with electrohydraulic shock waves, its removal was made using conventional methods such as extractor balloon or basket (Boston Scientific).

RESULTS

From August to November 2013, 20 patients were consecutively included in this study. Eight (40%) were male and 12 (60%) female. The ages ranged from 14 to 94 years with mean and median of 58 and 48 years, respectively. Patient’s demographic, SpyGlass indications, ERCP and SpyGlass procedures are presented in Figure 3.

Main ERCP indication was choledocolitiasis (12) with stones ranging from 10 to 35 mm. EHL was performed in eight cases, with a success rate of 87.5% (seven cases) on fragmentation and stone removal (Figure 4). Failure occurred in one patient, despite successful lithotripsy therapy, stone removal was incomplete due to a disparity between the fragments of the stone post EHL and distal choledochal portion. CBD stenting was provided. In two cases, multiple giant stones were identified, and the distal ones were successfully treated with EHL followed by basket extraction. In order to avoid complications of a prolonged procedure plastic stent was placed and a second Spyglass cholangioscopy with EHL scheduled in 3 months. (Table 1)

FIGURE 4.
Fragmented stone post EHL. A: Radiologic view; B: Direct view

TABLE 1.
Choledocholitiasis analysis and performed procedures with SpyGlass

Size mean (range)	17.8 (10-35) mm
Estimated size
< 15mm	4
≥ 15 mm	7
No stone found	1
Location
Common bile duct	9
Common hepatic duct	1
Intrahepatic duct	1
Stone treated with EHL	8
Success	7
Failured (Stone-choledochal disproportion)	1

Biliary stricture was evaluated in eight patients. Malignancy was excluded in seven cases after cholangioscopy due to absence of protruding or friable lesions (Table 1). Only one patient presented an area of irregular and friable mucosa at the medial portion of the common bile duct, which was biopsied with Spybite and the histopathological evaluation did not evidenced malignancy.

In a patient with stricture of CBD anastomosis after orthotopic liver transplantation, it was possible to identify an annular stricture associated with biliary stasis, sludge and stones in proximal bile ducts. Balloon dilation of the stricture was performed, followed by SpyGlass electrohydraulic lithotripsy and successful clearance of the stone fragments.

In one case, it was not possible to advance the cholangioscopy equipment due to the scar stricture in the distal CBD. Papillary balloon dilation (10 mm) was required, but occurred a duodenal perforation. The patient was treated with clinical management and antibiotic therapy, but followed by cardiac complications and died 48 hours after the procedure.

There were no cases of cholangitis or other complications in this study.

DISCUSSION

The pioneering use of cholangioscopy in our Brazilian study with SpyGlass significantly expanded the diagnostic and therapeutic possibilities of biliary diseases, especially in cases of difficult management with conventional methods, either endoscopic or radiologic. However, applications of this method are still limited to large centers, as a result of its high cost and technical difficulties⁽⁵⁾.

SpyGlass cholangioscopy main benefits are evaluation of strictures and treatment of large CBD stones, in which electrohydraulic lithotripsy is the major therapeutic application. Thereby in our case series, therapeutic success of EHL was achieved in 87.5% (7/8) of the patients, which is similar to current literature that reports success rates ranging from 85% to 97%^{(3, 4, 10, 12)}.

Peroral cholangioscopy provides direct visual evaluation of the bile duct, thus allowing guided tissue sampling^{(5, 8)}. The addition of cholangioscopy findings increased diagnostic accuracy of malignant bile duct strictures to more than 90%^{(6, 14)}. In a study of Siddiqui et al.⁽¹⁵⁾, SpyGlass system had 77% accuracy in diagnosis of malignancies that were inconclusive on the basis of ERCP-guided brush or EUS fine-needle aspiration analyses. In this case series, SpyGlass evaluation for biliary strictures of undetermined cause were performed in 8 patients; however there was only one case with suspected bile duct lesion on cholangioscopy. This lesion was biopsied under direct view, and anatomopathological analysis resulted negative for malignancy despite appropriate tissue sampling. In the other seven cases, cholangioscopy was able to avoid further procedures, once no endoscopic findings of malignancy on bile duct were identified. Based on this, the supposition that ERCP findings of undeterminated biliary stricture should lead to cholangioscopic evaluation is valid. However, our results may not be conclusive once our case number was restricted to eight non-prospective patients.

Since its creation, the range of cholangioscopy diagnostic and therapeutic procedures is increasing. Besides EHL therapy it has been described several others feasible procedures such as laser lithotripsy, photodynamic therapy in biliary neoplasms, endomicroscopy mucosal analysis, and assistance in the upstream of guidewire over choledochal complex strictures. Other indications are being studied, such as pancreatography, assisting in the differential diagnosis of pancreatic diseases.

The most commom complication of SpyGlass cholangioscopy is acute cholangitis, occurring in 3.1% of cases⁽¹⁶⁾. Other complications described are: bacteremia (0.9%), transient hypotension (0.9%), abdominal pain and distension (0.9%), pancreatitis (0.4%), and hyperamylasemia (0.4%). Bile duct perforation was reported in one (1.5%) case. Minor hemobilia without clinical repercussions after electrohydraulic lithotripsy was observed in up to 20% of the patients⁽¹²⁾. In our study, there were no complications related to the SpyGlass procedure, once the duodenal perforation resulted from papillary balloon dilation.

Despite being a revolutionary technique, there are still some limitations such as high cost and small working channel diameter (1.2 mm), which requires the use of specific accessories. Besides this method incorporation, professional training and technique development are extremely important, as well as image qualities improvements and a guideline on exam indication criteria. Therefore, experienced endoscopists require a learning curve to handle the equipment, to perform therapeutic procedures, and to proper analyze cholangioscopic findings⁽⁹⁾.

This case series demonstrated that cholangioscopy with Spyglass platform is helpful in selected cases, especially those difficult to handle with conventional endoscopic techniques. In addition, we observed potential advantages such as reduction of radiation exposure due to direct visualization of the bile duct. Cholangioscopy shows up extremely promising horizons for both diagnosis and therapy in bile duct disease. The development of imaging technology and accessories should not be a very distant reality. Certainly more and more studies will be published solidifying the threshold of this new frontier by gastrointestinal endoscopy.

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Publication Dates

• Publication in this collection
  Jul-Sep 2014

History

• Received
  28 Jan 2014
• Accepted
  25 Mar 2014