Efficacy and safety of precut sphincterotomy for therapeutic ERCP: a prospective study in a tertiary referral center

BACKGROUND: Therapeutic endoscopic retrograde cholangiopancreatography (ERCP) involves selective cannulation of the common bile and/or pancreatic ducts. If the cannulation fails, there is the choice whether to use more invasive procedures (i.d. precut papillotomy) or stop the esamination and proceed with alternative methods (i.d. percutaneous transhepatic biliary drainage - PTBD). OBJECTIVES: To compare the success and complication rates of precut papillotomy and of standard endoscopic sphincterotomy (EST). In cases of ERCP failure, to identify treatments used and its complications. METHODS: A prospective observational study was carried out on patients who underwent ERCP in a tertiary referral university hospital between January 2007 and April 2010. Two groups were studied: a) all the patients who underwent precut papillotomy; b) a subgroup of patients who underwent a standard EST (consecutively selecting a patient every four). The success and complication rates associated to the various methods were considered the main outcome measurements. RESULTS: A total of 783 ERCPs were performed, 755 with therapeutic intent. A precut papillotomy was carried out in 17.3% of total therapeutic ERCP (131/755; 51.1% females; mean age 65.5±13.7). The overall success rate was 73.3% (96/131) with an intra-operator variability between 63.1% and 83.3%. The complication rate was 5.3% (7/131); there were no cases of death. In this group 46.6% of cases were classified as presenting a high grade of difficulty (grade 3 of Cotton’s classification). The grade of difficulty was found to be inversely correlated with the success rate (p<0.01) but not with the complication rate. Papillotomy failed in 35 patients who then underwent: PTBD in 18 cases (51.4%), medical treatment and radiological follow-up in 11 (31.4%), and surgery in 6 (17.2%). PTBD was associated to a 22.2% rate of complications (2 cholangitis and 2 bleeding requiring blood transfusion). A standard EST was carried out in 151 cases (corresponding to 20% of the total therapeutic ERCPs): 56.3% female; mean age 63.5±17.6. The overall success rate was 92.7% (140/151) with an intra-operator variability between 88.8% and 97.2%. The complication rate was 7.3% (11/151). Twenty-five percent of standard EST were graded as presenting a high degree of difficulty (grade 3 of Cotton’s classification). If only severe complications are considered, there is only a slight prevalence in the precut group (2.3%) with respect to the standard EST group (1.3%) (p=ns). CONCLUSION: In a consecutive series of patients with a high proportion of difficult cases, papilla precutting is an useful technique with an acceptable complication rate.