BACKGROUND: The aim of this prospective study was to evaluate and compare the efficacy and safety of two different precutting techniques in the treatment of 103 consecutive patients with choledocholithiasis. METHODS: The patients were randomized into two groups. The first group included 74 patients who underwentneedle-knife fistulotomy avoiding the papillary orifice followed by standard papillotomy. Fifty-two of these patients had a final diagnosis of choledocholithiasis. The second group included 79 patients who underwentneedle-knife precut papillotomy starting from the papillary orifice followed by standard papillotomy. Fifty-one of these patients had a final diagnosis of choledocholithiasis. RESULTS: Precutting was successful in 90.54% of patients in the needle-knife fistulotomy group and 88.6% of patients in the needle-knife precut papillotomy group. Stone extraction without mechanical lithotripsy was achieved in 40 of 48 (83.33%) patients in the needle-knife fistulotomy group and 45 of 46 (97.82%) patients in the needle-knife precut papillotomy group (p < 0.05). For the other patients, stone extraction was achieved with the aid of a mechanical lithotriptor. Complications were as follows for the needle-knife fistulotomy and needle-knife precut papillotomy groups, respectively: bleeding, 6.75% and 5.06%; perforation, 2.7% and 2. 53%; cholangitis, 1.35% and 0; pancreatitis, 0 and 7.59% (p < 0.05); hyperamylasemia, 2.7% and 17.72% (p < 0.01); and death, 0 and 1.26%. CONCLUSIONS: Both methods are effective in the management of choledocholithiasis. When needle-knife fistulotomy is performed, however, lithotripsy is needed more often. Needle-knife fistulotomy is safer than needle-knife precut papillotomy with respect to pancreatic complications.
RCT Entities:
BACKGROUND: The aim of this prospective study was to evaluate and compare the efficacy and safety of two different precutting techniques in the treatment of 103 consecutive patients with choledocholithiasis. METHODS: The patients were randomized into two groups. The first group included 74 patients who underwent needle-knife fistulotomy avoiding the papillary orifice followed by standard papillotomy. Fifty-two of these patients had a final diagnosis of choledocholithiasis. The second group included 79 patients who underwent needle-knife precut papillotomy starting from the papillary orifice followed by standard papillotomy. Fifty-one of these patients had a final diagnosis of choledocholithiasis. RESULTS: Precutting was successful in 90.54% of patients in the needle-knife fistulotomy group and 88.6% of patients in the needle-knife precut papillotomy group. Stone extraction without mechanical lithotripsy was achieved in 40 of 48 (83.33%) patients in the needle-knife fistulotomy group and 45 of 46 (97.82%) patients in the needle-knife precut papillotomy group (p < 0.05). For the other patients, stone extraction was achieved with the aid of a mechanical lithotriptor. Complications were as follows for the needle-knife fistulotomy and needle-knife precut papillotomy groups, respectively: bleeding, 6.75% and 5.06%; perforation, 2.7% and 2. 53%; cholangitis, 1.35% and 0; pancreatitis, 0 and 7.59% (p < 0.05); hyperamylasemia, 2.7% and 17.72% (p < 0.01); and death, 0 and 1.26%. CONCLUSIONS: Both methods are effective in the management of choledocholithiasis. When needle-knife fistulotomy is performed, however, lithotripsy is needed more often. Needle-knife fistulotomy is safer than needle-knife precut papillotomy with respect to pancreatic complications.