Background and aim: Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate. The aim of our study is to test the loop-tip wire for the prevention of PEP and biliary tree access in high-risk patients.Material and methods: Prospective, randomized, multicenter study. 254 PEP high-risk patients were prospectively enrolled and divided in two groups. Inclusion criteria: previous pancreatitis; CBD diameter <1cm; sphincter of Oddi type-1 dysfunction (SOD1); age<40yrs; female sex associated with another risk factors. In group 1 biliary tree cannulation was obtained with the loop-tip; in group 2 with the conventional contrast cannulation technique. The cannulation attempt were composed of two phases: phase1: 5 minutes attempts or a maximum of 5 attempts of main pancreatic duct (MPD) cannulation or 3 attempts of MPD opacification if group 2. If phase1 failed there was the phase 2: 5 minutes or a maximum of 5 MPD cannulation attempts with the wire. If there was no CBD cannulation after phase 2 we declared the “technical cannulation failure”. Serum amylases were dosed before and 24h after ERCP. Pancreatitis was diagnosed according to Cotton’s criteria. Results: Group 1 (123pts) and group 2 (131pts) were matched for sex (74F;49M vs 70F;61M) and age (64.4±15.1 vs 65.1±17.2yrs). Indication for ERCP were: CBD stones 85.8% (218/254pts); intrahepatic stones 0.7% (2/254pts); SOD1 13.8% (35/254pts); cholangitis 14.5% (37/254pts); biliary leak 3.5% (9/254pts). Overall technical success was similar in the two groups (121/123 pts – 98.4% vs 123/131 pts – 93.9%; p:ns). Number of CBD cannulation attempts was lower in group 1 in the phase 1 (3.4±2.5 vs 4.2±2.7; p<0.02) and in the phase 2 (4.7±2.5 vs 5.7±3.1; p:ns). PEP was significantly lower in group 1 (5/123pts – 4.1% vs 15/131pts – 11.4%; p<0.01). Serum amylase 24h after ERCP were significantly lower in group 1 (276.4±401.9 vs 393.3±748.2U/lt; p<0.01). Conclusions: This ad-interim results show that loop-tip wire provides a minor number of cannulation CBD attempts; a significant minor PEP rate and a significant minor post-ERCP serum hyperamylasemia.
Ad interim analysis of the italian study on the comparison of loop-tip Cook medical® wire vs traditional endoscopic technique cannulation in the prevention of post-ERCP pancreatitis and biliary tree access in high-risk patients
Mangiavillano B;
2013-01-01
Abstract
Background and aim: Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate. The aim of our study is to test the loop-tip wire for the prevention of PEP and biliary tree access in high-risk patients.Material and methods: Prospective, randomized, multicenter study. 254 PEP high-risk patients were prospectively enrolled and divided in two groups. Inclusion criteria: previous pancreatitis; CBD diameter <1cm; sphincter of Oddi type-1 dysfunction (SOD1); age<40yrs; female sex associated with another risk factors. In group 1 biliary tree cannulation was obtained with the loop-tip; in group 2 with the conventional contrast cannulation technique. The cannulation attempt were composed of two phases: phase1: 5 minutes attempts or a maximum of 5 attempts of main pancreatic duct (MPD) cannulation or 3 attempts of MPD opacification if group 2. If phase1 failed there was the phase 2: 5 minutes or a maximum of 5 MPD cannulation attempts with the wire. If there was no CBD cannulation after phase 2 we declared the “technical cannulation failure”. Serum amylases were dosed before and 24h after ERCP. Pancreatitis was diagnosed according to Cotton’s criteria. Results: Group 1 (123pts) and group 2 (131pts) were matched for sex (74F;49M vs 70F;61M) and age (64.4±15.1 vs 65.1±17.2yrs). Indication for ERCP were: CBD stones 85.8% (218/254pts); intrahepatic stones 0.7% (2/254pts); SOD1 13.8% (35/254pts); cholangitis 14.5% (37/254pts); biliary leak 3.5% (9/254pts). Overall technical success was similar in the two groups (121/123 pts – 98.4% vs 123/131 pts – 93.9%; p:ns). Number of CBD cannulation attempts was lower in group 1 in the phase 1 (3.4±2.5 vs 4.2±2.7; p<0.02) and in the phase 2 (4.7±2.5 vs 5.7±3.1; p:ns). PEP was significantly lower in group 1 (5/123pts – 4.1% vs 15/131pts – 11.4%; p<0.01). Serum amylase 24h after ERCP were significantly lower in group 1 (276.4±401.9 vs 393.3±748.2U/lt; p<0.01). Conclusions: This ad-interim results show that loop-tip wire provides a minor number of cannulation CBD attempts; a significant minor PEP rate and a significant minor post-ERCP serum hyperamylasemia.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
