Early ductal decompression versus conservative management for gallstone pancreatitis with ampullary obstruction - A prospective randomized clinical trial

Objective: To compare the efficacy of endoscopic retrograde cholangiopancreatography +/- endoscopic sphincterotomy (ERCP +/- ES) versus traditional conservative management in early gallstone pancreatitis with persistent ampullary obstruction (GSP + AO). Summary Background Data: The effectiveness of early ERCP +/- ES in this setting is controversial. Methods: Sixty-one consecutive patients with GSP + AO within 48 hours from the onset of symptoms were randomized to receive either conservative treatment and selective ERCP +/- ES after 48 hours (control group, 31 patients) or initial conservative treatment and systematic ERCP +/- ES within 48 hours if obstruction persisted 24 hours or longer (study group, 30 patients). Patient outcome was compared in relation to treatment groups and to duration of obstruction. Results: In the control group, 22 patients disobstructed spontaneously within 48 hours; 3 of the remaining 9 patients underwent ERCP +/- ES and none had impacted stones. In the study group, 16 patients disobstructed spontaneously and 14 underwent ERCP within 48 hours from the onset of symptoms; impacted stones were found and extracted by ES in 79% (11 of 14) of these. Patients: There were no deaths in either group. Patients in the study group showed a shorter period of obstruction (P = 0.016) and a lower rate of immediate complications (P = 0.026) than controls. Patients with obstruction lasting <= 48 hours regardless of the treatment group had fewer immediate complications than those whose obstruction persisted longer (P < 0.001). Conclusions: This study shows that in patients with GSP + AO limiting the duration of obstruction to not longer than 48 hours by ERCP + ES decreased morbidity.