This retrospective study was approved by the Committee on Human Research of the Institutional Review Board at our institution. The requirement for informed consent for participation in the study was waived. Between March 1995 and August 2010, 61 patients (40 women and 21 men; average age at referral 52.6 years; range 23–82 years) were referred to our institution for management of biliary obstruction that developed at the biliary-enteric anastomosis created for laparoscopic
cholecystectomy-related bile duct injuries. Based on the recommendation by the treating hepatobiliary surgeon, 27 of these patients underwent surgical revision, whereas 34 patients (23 women and 11 men; average age at referral 53.4 years; range 28–82 years) were treated with balloon dilation. A total of 20 patients had an injury to the common hepatic duct (7 Bismuth type 1 and 13 Bismuth type 2), while injuries at the liver hilum were sustained in 6 patients (Bismuth type 3). Three patients had injuries to the right hepatic duct (Bismuth type 4), and 3 patients had injuries to the aberrantly inserting right posterior duct draining segments 6 and 7 of the liver (Bismuth type 5). Location of injury could not be determined from the available records in 2 patients 
. Presence or absence of a concomitant hepatic artery injury could not be ascertained based on the available records.
Strictures at the biliary-enteric anastomosis occurred following hepaticojejunostomy in 26 patients, choledochojejunostomy in 5 patients, or choledochoduodenostomy in 3 patients.. The mean time to stricture formation after surgical repair was 2.3 years (range 0–15.3 years). Mean total serum bilirubin level at time of admission was 3.9 mg/dL (range 0.8–13.5 mg/dL; normal range 0.3–1.2 mg/dL). Symptoms at admission included jaundice, chills, fever, abdominal pain, pruritus, weight loss and rigors. The average follow-up period for the study population was 13.1 years (median 11.8 years, range 1.9–17.4 years).
The primary study objective was to determine the clinical success rate of balloon dilation of biliary-enteric anastomotic strictures following surgical repair of laparoscopic cholecystectomy-related bile duct injuries. Clinical success was defined as resolution of biliary-enteric anastomotic stricture on tube cholangiogram (less than 30% residual narrowing at the biliary-enteric anastomosis when compared to the caliber of the bile duct at the cranial aspect of the anastomosis) associated with normalization of serum bilirubin (if elevated) and elimination of pruritus or other clinical symptoms (if present) allowing removal of the external biliary catheter. Secondary study objectives were to (a) evaluate patency of the anastomoses over time, (b) determine the rates of stricture recurrence following a clinically successful balloon dilation, and (c) analyze morbidity to patients associated with treatment of biliary-enteric anastomotic strictures. Duration of biliary-enteric anastomosis patency was defined as the time between removal of the external biliary catheter till documentation of stricture recurrence on a subsequent cholangiogram, a patient's death, or completion of the data analysis period (July 1, 2012). Clinical signs of stricture recurrence included jaundice, pruritus, abdominal pain, anorexia, nausea or vomiting, elevated serum bilirubin, and evidence of new or worsening intrahepatic biliary ductal dilatation on imaging (performed by contrast-enhanced CT or MRI). Due to the retrospective nature of the analysis, information on morbidity was based on the number of invasive procedures performed in the interventional radiology suite or in the operating room, the number of balloon dilation sessions or surgical operations, time period spent with an indwelling biliary catheter, number of hospitalizations for management of a bile duct-related problem (i.e. cholangitis, hemobilia), and the number and type of complications related to treatment.
The types of interventional radiology procedures tracked for the study purposes included biliary drain injections with contrast (tube check), PTBD exchanges, side-arm sheath cholangiograms, and balloon dilation sessions. If multiple interventional radiology procedures were performed on a given day, only the most complex procedure was counted. The order of procedure complexity increased from biliary drain injection with contrast (i.e. tube check; least complex) to tube exchange over a guidewire, to side-arm sheath cholangiogram (exchange of a biliary drain to a side-arm sheath over a guidewire followed by cholangiogram through the side-arm sheath; this procedure was performed to assess anastomosis patency and was preceded all balloon dilations), to balloon dilation (most complex). For example, if a patient had a drain check followed by a side-arm sheath cholangiogram, balloon dilation and PTBD replacement, the procedure was counted as “balloon dilation”. The time period spent with an indwelling biliary catheter was calculated from the day of PTBD insertion to the day of tube removal (either following successful balloon dilation or after surgical revision). Hospitalizations for bile duct-related problems that occurred after PTBD insertion were tracked as well.
Management of Biliary-Enteric Anastomotic Strictures
Upon referral to our institution, all patients first underwent percutaneous transhepatic cholangiography (PTC) followed by placement of a percutaneous transhepatic biliary drain (PTBD). Subsequently, 34 patients were managed with balloon dilation. Two patients were lost to follow-up ().
Figure 1 Flow chart of the study subjects (n=number of patients).
Treatment algorithm for patients managed with balloon dilation is summarized in . Balloon dilation was performed at the time of PTBD insertion or 3–14 days following drain placement. Timing of the first balloon dilation session was at the discretion of the treating interventional radiologist. Balloon dilation was performed on the same day as PTBD only if duct catheterization was technically straightforward. The first balloon dilation session was performed with 6–10 mm diameter by 40 mm angioplasty balloons (Boston Scientific, Natick MA; maximum inflation pressure 10 atm). The duration of inflation was approximately 60 seconds. Maximum balloon diameter was selected based on the caliber of the bile duct proximal to the anastomotic stricture. Anastomotic patency following balloon dilation was defined as greater than 70% of bile duct caliber proximal to the biliary-enteric anastomosis on cholangiography. Following balloon dilation, a 10.2 French internal-external biliary drainage catheter (Cook Inc., Bloomington, IN) was left in place with catheter tip in the Roux limb for a period of six weeks. At the completion of the six-week interval, patients returned for a side-arm sheath cholangiogram to assess patency of the biliary-enteric anastomosis.
Treatment algorithm for patients with biliary anastomotic strictures who underwent at least one balloon dilation (32 patients).
Prior to 2002, if a persistent anastomotic narrowing greater than 30% of bile duct caliber was demonstrated on a follow-up cholangiogram, balloon dilation of the biliary stricture was repeated, as described above. Beginning in 2002, a repeat balloon dilation was performed with an 8–10 mm by 40 mm high-pressure balloon for 60 seconds (Conquest, Bard Inc., Murray Hill, NJ; maximum inflation pressure 24 atm) in 15 patients. After 2005, if anastomotic patency could not be restored with a high pressure balloon, a 6–8 mm by 20 mm cutting balloon (Boston Scientific) was used followed by repeat dilation with a larger diameter high-pressure balloon up to 24 atm in 2 patients. Following balloon dilation, the PTBD was replaced and was left in place for an additional six weeks after each balloon dilation session. If the anastomosis was found to be patent on the follow-up cholangiogram (less than 30% residual stenosis), a 10 French external biliary drainage catheter (Malecot, Bard) was capped and left in place above the stricture for a period of an additional two weeks. The drainage catheter was removed if the repeat tube cholangiogram demonstrated persistent patency of the anastomosis. Alternatively, recurrent or residual anastomotic stricture was treated with repeat balloon dilation ().
At the beginning of the study period (1995–1999), patients were referred for surgical revision of the biliary-enteric anastomosis if a single attempt at balloon dilation of the anastomosis proved unsuccessful. After 2000, patients were referred to surgery after biliary strictures remained after two or more balloon dilation sessions. After the biliary drain removal, patients were instructed to return to their hepatobiliary surgeon at our institution if they experienced any recurrent biliary obstruction symptoms (jaundice, abdominal pain, fever, nausea, anorexia). Follow-up was conducted via a retrospective review of medical records and by searching the Social Security Death Index.
Statistical analysis was performed using Sas version 9.2 software (Sas Institute, Cary, IN). Continuous variables such as number of interventional radiology procedures, number of balloon dilations, maximum balloon diameter, time period with indwelling biliary catheter, and number of hospitalizations were analyzed using Student's T-test. Discrete variables, such as the number of patients who developed a recurrent stricture and individual complications were compared using Fisher's exact test. A p-value<0.05 was considered statistically significant.