Impact of endoscopic papillary large-balloon dilation on sphincter of Oddi function: a prospective randomized study.
OBJECTIVE
Endoscopic papillary balloon dilation (≤8 mm in diameter) preserves sphincter of Oddi (SO) function. However, it is still unknown whether papillary function is preserved after endoscopic papillary large-balloon dilation (EPLBD, ≥12 mm in diameter). We investigated SO function after EPLBD with or without endoscopic sphincterotomy (EST) by endoscopic manometry, up to 1 year after the procedure.


METHODS
This was a prospective randomized study involving patients with bile duct stones ≥12 mm. Eighty-six patients who met the inclusion criteria were assigned randomly to either EPLBD alone or EST with EPLBD, and endoscopic manometric studies were performed. The primary outcome was comparison of the manometric data between the 2 groups and within each group both 1 week and 1 year after the procedure.


RESULTS
One week after EPLBD alone and EST with EPLBD, the basal pressure of SO dropped from 30.4 (8.2) to 6.4 (8.4) mm Hg (P < .001) and 29.5 (18.9) to 2.9 (3.6) mm Hg (P < .001), respectively. SO function was not recovered at 1 year; the manometric measurements were similar to those taken at the 1-week time point in both groups. Similar outcomes were obtained in patients with EPLBD alone compared with those with EST and EPLBD, including the initial stone clearance rate (95.2% vs 97.7%, P = .612), the frequency of mechanical lithotripsy (21.4% vs 13.6%), and overall adverse events (11.9% vs 13.6%, P = 1.0) including the rate of pancreatitis after the procedure (7.1% vs 11.4%, P = .714). During an overall median follow-up of 17.8 months, the recurrence rate of bile duct stones was 16.7% in patients who underwent EPLBD alone and 15.9% in patients who underwent EST with EPLBD (P = .924).


CONCLUSIONS
Both EPLBD alone and EST + EPLBD resulted in persistent and comparable loss of SO function after 1 year. EPLBD alone has similar efficacy and safety to those of EST with EPLBD with respect to removal of large stones.
Digestive Disease Center, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
Young Koog
YK
Cheon
Digestive Disease Center, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
Tae Yoon
TY
Lee
Department of Obstetrics and Gynecology, Konkuk University School of Medicine, Seoul, Korea.
Soo-Nyung
SN
Kim
Digestive Disease Center, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
Chan Sup
CS
Shim
D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods; D042883:Choledocholithiasis / Q000601:surgery*; D003137:Common Bile Duct Diseases / Q000453:epidemiology* / Q000503:physiopathology; D004106:Dilatation / Q000379:methods*; D016145:Endoscopy, Digestive System; D005260:Female; D006801:Humans; D008096:Lithotripsy / Q000379:methods; D008297:Male; D008365:Manometry; D008875:Middle Aged; D010195:Pancreatitis / Q000453:epidemiology; D011183:Postoperative Complications / Q000453:epidemiology* / Q000503:physiopathology; D016016:Proportional Hazards Models; D012008:Recurrence; D009803:Sphincter of Oddi / Q000503:physiopathology*; D016717:Sphincterotomy, Endoscopic / Q000379:methods*