Safety and Efficacy of Endoscopic Ampullectomy in Tumors with and Without Intraductal Growth and Predictive Factors of Success: A Prospective Trial

Abstract

Introduction: Endoscopic treatment of benign ampullary tumors has been well described with favorable results in comparison to surgical alternatives, yet there is a paucity of studies evaluating the efficacy of this technique in treating ampullary tumors with intraductal extension. The factors predictive of complications and recurrence using this technique are also not well defined. This is a prospective study evaluating the safety and efficacy of endoscopic ampullectomy in treating tumors with and without intraductal extension and assessing possible predictive factors of complications and tumor recurrence. Patients and Methods: During the period between December 2003 and June 2007 consecutive patients presenting with ampullary tumors proven by endoscopic biopsies were recruited. Extensive invasion and lymph node involvement were excluded by endoscopic ultrasound, tumors with intraductal growth involving the lower third of common bile duct were not excluded. Snare ampullectomy was performed, for tumors with intraductal extension an extended sphincterotomy was done to expose and excise intraductal portions of the tumor. Clinical and endoscopic surveillance with targeted or routine biopsies and endoscopic ultrasound was performed every 6 months. Tumor recurrences were treated endoscopicaly. Statistical analysis was performed on the following variables to detect association with tumor recurrence and complications: Sex, age, FAP, tumor size, dilatation of biliary or pancreatic ducts, intraductal extension, submucous injection and pancreatic stents. Results:20 patients were included; 16 males, mean age 61 years (42-79). Mean tumor diameter = 19 mm (5-40 mm). Intraductal tumor growth n = 6 (30%). Monobloc resection n = 13, piecemeal n = 7. Complications occured in 9 patients (47%): pancreatitis n = 6 (30%, 1 mild, 4 moderate, 1 severe), hemorrhage n = 3(16%), cholangitis n = 1, perforation n = 1, duodenal stenosis n = 1. Mean duration of follow up = 17.5 months (2-40). Recurrence occurred in 6 patients (30%) who received further endoscopic resections and/or argon plasma coagulation. The final success rate (with no residual tumor) was 85%. No variables showed association with complications. Intraductal tumor extension and piecemeal resection were significantly associated with tumor recurrence (p = 0.002 and p = 0.007 respectively, fisher's exact). Conclusion: Endoscopic ampullectomy is an effective method in the treatment of benign ampullary tumors. Intraductal tumor growth and piecemeal resection are associated with a higher rate of recurrence yet recurrences are amenable to endoscopic treatment. No factors seem to be predictive of the occurrence of complications.