Early Ductal Decompression Versus Conservative Management for Gallstone Pancreatitis With Ampullary Obstruction: A Prospective Randomized Clinical Trial

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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.

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