Objectives: To determine the frequency of complications, specifically pancreatitis, associated with endoscopic sphincterotomy, comparing the standard, monopolar electrocautery current to the bipolar system.
Methods: One-hundred consecutive patients requiring ERCP and sphincterotomy, 50 patients in each group, were randomized to receive a sphincterotomy using either the bipolar system (Bitome) or the standard monopolar system. Cannulation with the selected sphincterotome was successful in 92 patients, but crossover to the other system was necessary in eight patients, five bipolar and three monopolar. The performance of sphincterotomy was conducted similarly and by the same investigator. Excessive manipulation of the papilla during difficult cannulation was avoided, and no pre-cut, needle knife, or wire-guided assisted cannulation techniques were used in either group.
Results: Complications were assessed during follow-up review of charts and telephone interviews. Pancreatitis did not occur in the bipolar group; however, six patients in the monopolar group developed clinical and biochemical evidence of pancreatitis (p < 0.047).
Conclusions: Sphincterotomy using bipolar technology appears to reduce the frequency of pancreatitis when compared to monopolar technology in a prospective, randomized fashion. Because bipolar electrocautery current is localized to the accessory tip, radiofrequency does not encounter impedance through the patient's body mass, and tissue injury is reduced. This fact may account for the decreased incidence of pancreatitis in the bipolar group. Larger studies are called for to support this conclusion.