Two randomized controlled trials comparing endoscopic nasobiliary drainage (ENBD) and internal endoscopic biliary drainage (internal EBD) for acute suppurative cholangitis (ASC) showed no significant difference in efficacy and both preferred internal EBD to ENBD. In this study, the necessity of ENBD was re-examined. Over five years, 59 patients underwent an emergency endoscopic procedure for ASC in our institute. If drainage was needed, we selected internal EBD as a first choice and ENBD was used in patients predicted to have early obstruction of the tube or retrograde infection of the bile duct. The rate of ENBD, for which reason ENBD was selected, and the efficacy of drainage were examined retrospectively. In the 59 patients, 40 patients had the stones completely removed without drainage, five internal EBD and two ENBD were performed without removal of stones and five internal EBD and seven ENBD were performed after removal of stones. In terms of white blood cell count and direct bilirubin level, no significant difference was observed between ENBD and internal EBD patients. ENBD was mainly selected for the patients with multiple biliary strictures, hemorrhage tendency and excessive purulent bile. Even though internal drainage is suitable in many ASC patients, ENBD is necessary in selected patients.
Acute suppurative cholangitis (ASC) is a life-threatening condition that requires prompt and accurate drainage.1,2 Biliary drainage can be achieved with three different procedures: endoscopic, percutaneous transhepatic, and open drainage.3 Endoscopic drainage is often performed as the first choice for ASC because of the safety and low mortality rate.4,5
There are two endoscopic drainage methods, endoscopic nasobiliary drainage (ENBD, external drainage) and internal endoscopic biliary drainage (internal EBD). Two randomized controlled trials (RCT) comparing ENBD and internal EBD showed no significant differences in success rate, efficacy, or morbidity.6,7 One study of the two RCT revealed that the incidence of tube troubles, such as removal of the tube by patients themselves, tended to be higher with ENBD and there was a significantly lower mean patient discomfort score on day 1 after the procedure.6 Therefore, we examined whether drainage of ASC is possible with just internal EBD and whether ENBD is unnecessary for the drainage of ASC.
In this study, patients who underwent ENBD for ASC in our institute were examined retrospectively and the necessity of ENBD was re-examined.
From July 2004 to June 2009, 59 patients underwent emergency endoscopic biliary drainage or removal of bile duct stones for ASC in our institute. Severe acute cholangitis is defined as that which accompanies the onset of organ dysfunction. Patients who respond to initial medical treatment are classified as mild acute cholangitis and neither severe nor mild cholangitis is defined as moderate acute cholangitis.8 Urgent biliary drainage is recommended for severe acute cholangitis and early biliary drainage is recommended for moderate acute cholangitis in the Tokyo Consensus Meeting.9 Although there is no evidence that purulent bile is related to severity or mortality of acute cholangitis, ASC is defined based on clinical signs such as Charcot's triad (fever and/or chills, abdominal pain, and jaundice) accompanying septic shock (systolic blood pressure below 90 mmHg), impaired consciousness, or evidence of purulent bile in this study. The ERCP procedure was performed in all patients within 12 hours after hospital admission. All patients were treated with intravenously administered antibiotics. Written informed consent for the procedures was obtained from all patients. The ERCP procedures were performed with a backward oblique-viewing duodenoscope (JF-240, JF-260V; Olympus Optical, Tokyo, Japan). We performed endoscopic drainage without removal of stones for patients with ASC who were in generally poor condition, such as those in shock, and those who had taken antiplatelet agents or anticoagulants. In the other patients, we performed endoscopic sphincterotomy or endoscopic papillary balloon dilatation (EPBD)10 and removed the bile duct stones. Only in patients with remaining stones or debris were internal EBD or ENBD used.
We selected internal EBD as a first choice for drainage of ASC, and ENBD was used in patients who were likely to have early obstruction of tube stents or retrograde infection of the bile duct.11,12
The tube stent used for internal EBD was an 8.5-F straight plastic tube, and a 7-F pig-tail tube with side hole was used for ENBD. The output from the ENBD was charted every 6 hours and the ENBD was flushed if needed. The rate of ENBD patients, the reason ENBD was selected, the efficacy of drainage and the complications of treatment were examined retrospectively. The Mann–Whitney U-test was used for continuous variables that appeared to have a skewed distribution, and the χ2-test was used with the Yates correction for categorical variables.
Of the 59 patients, 40 patients had bile duct stones removed completely without drainage at a single session; seven patients (five internal EBD patients; two ENBD patients) underwent only endoscopic drainage without removal of stones; and 12 patients (five internal EBD patients; seven ENBD patients) underwent endoscopic drainage after removal of stones because of remaining stones or excessive debris.
Patients that were in a state of disseminated intravascular coagulation (DIC) with excessive purulent bile and those who had taken anticoagulants with extensive debris in the bile duct proved by intraductal ultrasonography (IDUS)13,14 were given a nasobiliary tube without removal of stones. The reasons nasobiliary tubes were placed after removal of stones were extensive purulent bile or debris (five patients), multiple bile duct stricture due to primary sclerosing cholangitis (PSC) (one patient) and hemorrhage from the bile duct due to myelodysplastic syndrome (MDS) (one patient).
In the nine ENBD patients, the averages of body temperature, white blood cell (WBC) count and direct bilirubin level before drainage and 12 hours after the drainage were 38.2°C and 36.8°C, 11 866/mm3 and 11 111/mm3, 1.88 mg/dl and 1.82 mg/dl, respectively. In the 10 internal EBD patients, the averages of body temperature, WBC count and direct bilirubin level before drainage and 12 hours after the drainage were 38.6°C and 37.4°C, 12 000/mm3 and 10 240/mm3, 2.64 mg/dl and 1.93 mg/dl, respectively. For the improved WBC count and direct bilirubin level, no significant difference was observed between ENBD patients and internal EBD patients (Table 1). All patients reduced fever after drainage, but in two (22.2%) of nine ENBD patients and four (40.0%) of 10 internal EBD patients, WBC count increased after drainage. Post-procedure pancreatitis was observed in two internal EBD patients without removal of stones because of anticoagulant administration. No patient pulled out the nasobiliary catheter, and tube obstruction was not observed in the ENBD patients. There were no mortality cases in this study.
Table 1. Clinical characteristics and outcomes between the endoscopic nasobiliary drainage (ENBD) cases and the internal endoscopic biliary drainage (EBD) cases
ENBD (n = 9)
Internal EBD (n = 10)
F, female; M, male; SD, standard deviation.
Mean (SD) age (years)
Laboratory parameters (mean [SD])
White blood cell count (/mm3)
11 866 (5674)
12 000 (5306)
Direct bilirubin level (mg/dl)
After drainage (12 h)
White blood cell count (/mm3)
11 111 (5644)
10 240 (3418)
Direct bilirubin level (mg/dl)
Clinical progress 12 h after drainage
White blood cell count improved
Direct bilirubin level improved
Three patients in which ENBD was useful are presented.
Case 1. A 63-year-old woman was referred to our hospital because of poor general condition. Her body temperature was 40.9°C, and her blood pressure was 94/46. The laboratory data suggested that she was in DIC condition (WBC 24 000/mm3, platelet 24 000/mm3, C-reactive protein 35.4 mg/dl). Emergency endoscopic drainage was required (Fig. 1a). For the urgent management, ENBD was placed into the bile duct without removal of stones (Fig. 1b). It took 5 min 35 s for the total drainage procedure.
Case 2. A 70-year-old man was hospitalized because of ASC. The ERC findings showed multiple bile duct strictures and bile duct stones (Fig. 2a). Lithotripsy with a basket was performed (Fig. 2b) after EPBD. The IDUS findings showed debris in the bile duct so ENBD was placed into the bile duct to prevent post-procedure cholangitis.
Case 3. A 75-year-old man was hospitalized because of gastric ulcer bleeding. He had MDS. After bleeding was treated with an endoscopic procedure, ASC occurred. The endoscopic findings showed bleeding from the bile duct (Fig. 3a), and the ERC findings showed a small stone in the bile duct. EPBD was performed with a 6-mm-diameter balloon and lithotripsy was performed. After lithotripsy, bleeding from the bile duct continued (Fig. 3b). To prevent obstructive jaundice due to blood clot, ENBD was placed in the bile duct.
When we presented case 1 (mentioned above) in the Endoscopic Forum Japan 2009, the foreign faculties commented that they preferred internal drainage for ASC rather than ENBD. By contrast, in the Tokyo Consensus Meeting,3 Japanese faculties reported using internal drainage (3.7%), ENBD (38.5%), and both (61.5%) for ASC.
The safety and usefulness of endoscopic drainage has been proved by many studies.4,5 So, the Tokyo Guidelines recommended endoscopic biliary drainage for ASC.3 Two RCT6,7 comparing ENBD and internal drainage provided strong evidence that there were no significant differences between ENBD and internal drainage (internal EBD).
Certainly, internal EBD is more comfortable than ENBD for patients. In this study, it was also suggested that the drainage effects of internal EBD and ENBD were similar, as in the former RCT.6,7 But WBC count at 12 hours after drainage was elevated in 40% of internal EBD patients. Also, although there was no significant difference, the mortality rate was higher in the internal drainage group from the RCT reported by Lee et al.6 It is suggested that poor infection control in the early phase of ASC may be related to this result.
Although it is possible that ENBD can be accidentally removed, ENBD has several advantages in that a clogging tube can be washed out,15 retrograde infection is not considered likely,11,12 a bile culture can be done when necessary,15 the amount of bile flow can be monitored, cholangiography can be performed without endoscopic procedure, and so on.
Although we agree that internal drainage is selected as a first choice for the normal condition of ASC, ENBD is better for patients with multiple biliary strictures like PSC, those with hemorrhage tendencies, and those with extensive purulent bile or debris.
Based on our experience, internal drainage for ASC is suitable in many patients, but in selected patients, there is substantial necessity for ENBD and for drainage of ASC.