endoscopic papillectomy ( ep ) has evolved in recent years , and this technology has now been recognized as a safe and reliable treatment modality for benign tumors of the major duodenal papilla.110 one of the advantages of this method is that it does not require general anesthesia . the proper indication for ep is commonly agreed to be nonmalignant adenoma of the papilla of vater . ep can achieve complete en bloc resection of the lesion but may present technical difficulties in some cases . en bloc resection is fundamental for the treatment of neoplastic lesions and permits precise histopathologic evaluation of the specimen.5 sometimes , tumors that are diagnosed as adenomas based on biopsy specimens may contain malignant cells within the entire resected tumor . indeed , depending on the size of the adenoma and the presence of villous adenoma cells , carcinomatous cell deposits within the adenoma are found in 30% of patients.11 we investigated endoscopic double - snare retracting papillectomy as a new approach to ep . the advantages of this method are ( 1 ) snare constriction can be performed safely and securely by observing the tumor margin under the endoscopic field ; and ( 2 ) relatively deep vertical margins are obtained by pulling the tumor - grasping snare . here between january 2008 and november 2011 , 12 patients with tumors of the major duodenal papilla underwent ep . all of the patients provided informed consent for the procedure and were aware of the option for surgical treatment . the patients included seven men and five women , with a median age of 60.1 years ( range , 38 to 80 years ) . in all of the patients , a preprocedural diagnosis of adenoma tumor staging and ductal infiltration were estimated by endoscopic retrograde cholangiopancreatography ( ercp ) , endoscopic ultrasonography ( eus ) , or transpapillary intraductal ultrasonography ( idus ) . endoscopic double - snare retracting papillectomy was performed using a therapeutic duodenoscope with a 4.2-mm working channel ( tjf-240 ; olympus optical , tokyo , japan ) . after viewing the precise extent of the tumor by spraying a 0.5% solution of indigo carmine onto the surface , high - frequency hexagonal snares ( sd-6l-1 , maximum loop diameter of 22 mm ; olympus optical ) were inserted via the instrumental port . the  cutting snare  was hooked over the  pulling snare  before insertion . the papillary tumor was grasped by the pulling snare and pulled toward the duodenal lumen , making it easier to completely snare the papillary lesion . after releasing the pulling snare , the base of the papillary tumor was looped , and the cutting snare was tightened at a safe margin . en bloc papillectomy a nasobiliary drainage tube was placed in the bile duct of all of the patients . a plastic stent tube was placed in the pancreatic duct of all of the patients to avoid post - ercp pancreatitis . a follow - up endoscopy with biopsy was performed after 3 , 6 , and 12 months . in the case of benign recurrence , the tumors had a median size of 12.4 mm ( range , 8 to 20 mm ) . biliary stents were placed in 12 patients ( 100% ) , and pancreatic stents were placed in 11 patients ( 91.7% ) . hemorrhage was identified in one patient on the day after ep but was cured by endoscopic treatment . no other short- or long - term adverse events were identified during follow - up ( median , 28.5 months ; range , 2 to 48 months ) . the final histopathological diagnosis was tubular adenoma in seven patients ( 58.3% ) , tubulovillous adenoma in one ( 8.3% ) , hamartomatous polyp in one ( 8.3% ) , adenocarcinoma in adenoma in one ( 8.3% ) , and no neoplastic lesion in two ( 16.6% ) . macro- and/or microscopic tumor recurrence was observed in three of the 12 patients ( 25.0% ) but was successfully eradicated by repeat ep and argon plasma coagulation in all three cases , as indicated in the table 1 . a 63-year - old man was admitted to our department for the evaluation of an ampullary mass , detected by an endoscopy that was performed for screening purposes at a general hospital . laboratory data also showed no abnormalities . computed tomography and magnetic resonance imaging revealed a 2-cm mass in the descending part of the duodenum . duodenoscopy revealed a 2-cm - diameter exposed reddish mass in the papilla of vater ( fig . eus and ercp revealed a 20-mm hypoechoic mass in the papilla of vater without invasion of the duodenum , pancreas , bile duct terminus , or main pancreatic duct terminus ( fig . endoscopic double - snare papillectomy was performed . by grasping and pulling the tumor with the pulling snare , a stent was placed in the pancreatic duct , and a nasobiliary drainage tube was placed in the bile duct . neither macro- nor microscopic tumor recurrence was observed . the resected specimen consisted of a whitish exophytic tumor , 209.6 mm in size , in the ampulla of vater . follow - up endoscopy with biopsy was performed at 3 and 6 months postoperatively and every 6 months thereafter . however , no recurrence was observed after 48 months of follow - up ( fig . a 63-year - old man was admitted to our department for the evaluation of an ampullary mass , detected by an endoscopy that was performed for screening purposes at a general hospital . laboratory data also showed no abnormalities . computed tomography and magnetic resonance imaging revealed a 2-cm mass in the descending part of the duodenum . duodenoscopy revealed a 2-cm - diameter exposed reddish mass in the papilla of vater ( fig . eus and ercp revealed a 20-mm hypoechoic mass in the papilla of vater without invasion of the duodenum , pancreas , bile duct terminus , or main pancreatic duct terminus ( fig . endoscopic double - snare papillectomy was performed . by grasping and pulling the tumor with the pulling snare , a stent was placed in the pancreatic duct , and a nasobiliary drainage tube was placed in the bile duct . neither macro- nor microscopic tumor recurrence was observed . the resected specimen consisted of a whitish exophytic tumor , 209.6 mm in size , in the ampulla of vater . follow - up endoscopy with biopsy was performed at 3 and 6 months postoperatively and every 6 months thereafter . however , no recurrence was observed after 48 months of follow - up ( fig . double - snare retracting en bloc papillectomy is an effective and feasible treatment for patients with lesions of the major duodenal papilla . this method is also important clinically , as it can provide an accurate diagnosis , ensure an appropriate resection margin , and reduce the risk of unnecessary surgery . previous reports of ep procedures have described completion rates of 77% to 84%.10,12,13 in this study , we achieved a 100% success rate for en bloc resection using the double - snare retracting papillectomy technique . although this study included only a small number of patients , the results are certainly encouraging , and further data will be accumulated in the future . en bloc resection is considered fundamental for the treatment of neoplastic lesions and permits precise histopathological evaluation of the resected specimen . desilets et al.2 recommended piecemeal snare resection to successfully treat adenomas of the major duodenal papilla without a risk of recurrence and with a reduction in the frequency of adverse events , such as perforation and bleeding . however , piecemeal resection can increase the risk of tumor seeding , increase the number of ercp sessions that are required for eradication , and prevent precise histopathological assessments of the resection specimens . indeed , in the series by desilets et al.,2 an average of 2.7 ercp procedures were needed for piecemeal resection . it is commonly agreed that the indication for ep is nonmalignant adenoma of the papilla of vater , but establishing a diagnosis of adenoma in the area of the papilla of vater is difficult . a preresection diagnosis must therefore be carefully established ; in particular , ampullary cancer must be ruled out . eus and idus are extremely useful for such assessments because these modalities can demonstrate spread of the tumor within the bile and/or pancreatic ducts , as well as extension beyond the muscle layer of the duodenum . our results suggest that all 12 of the cases were localized within the ampullary region without intraductal invasion or muscle layer involvement . the evaluation of the surgical margins in the resected tissues revealed the complete resection of eight tumors and barely negative or unclear surgical margins in four tumors . as a result , the ep recurrence rate in the 12 patients was fairly high at 25% ( 3/12 ) , although we succeeded in eradicating the residual lesions . we could not identify the reason for the relatively high recurrence rate , due to the study s small sample size , and further research is needed . adverse events after ep treatment included pancreatitis , bleeding perforation , cholangitis , and papillary stenosis , reportedly occurring at rates of 15% to 22%.6,8,10,12,13 in the present study , one case of pancreatitis and one case of hemorrhage occurred ( 8.3% , 1/12 ) . although these patients recovered with endoscopic and/or medical treatments , the percentage of severe adverse events is not negligible . a recent prospective randomized controlled trial evaluating the role of pancreatic stent placement showed a significant decrease in the occurrence of post - ep pancreatitis.14 in our study , pancreatic stent placement was accomplished in 91.7% of cases , a rather higher success rate than the 4% to 88% reported previously.1,6,15 in conclusion , we performed endoscopic double - snare retracting papillectomy for 12 ampullary tumors . in all cases , the use of the endoscopic double - snare technique may help to perform ep safely and completely . further treatment experience is required before conducting a randomized study to compare the safety and efficacy of this technique with conventional ep .
we report herein improved methods for the safe and successful completion of endoscopic papillectomy ( ep ) . between january 2008 and november 2011 , 
 12 patients underwent double - snare retracting papillectomy for the treatment of lesions of the major duodenal papilla . 
 the main outcomes were en bloc resection rates , pathological findings , and adverse events . 
 all of the patients ( mean age , 60.1 years ; range , 38 to 80 years ) were diagnosed with ampullary adenoma by endoscopic forceps biopsies prior to endoscopic snare papillectomy . en bloc resection by double - snare retracting papillectomy was successfully performed for all lesions ( median size , 12.3 mm ) , comprising six tubular adenomas , one tubulovillous adenoma , three cases of epithelial atypia , one hamartomatous polyp , and one case of duodenitis with regenerative change . 
 significant hemorrhage and pancreatitis were observed in one case after ep . 
 adenoma recurrence occurred in three patients during follow - up ( median , 28.5 months ) at a mean interval of 2 months postoperatively ( range , 1 to 3 months ) . 
 no serious adverse events were observed . 
 double - snare retracting papillectomy is effective and feasible for treating lesions of the major duodenal papilla . further treatment experience , including a single - arm phase ii study , needs to be accumulated before conducting a randomized controlled study .