ERCP with Sphincter of Oddi Manometry (SOM) at an Ambulatory Endoscopy Center (AEC): An Assessment of Complications

Abstract

BACKGROUND: Patients (pts) with suspected sphincter of Oddi dysfunction (SOD) are known to be at increased risk for post-ERCP pancreatitis. At our tertiary referral center, outpatients undergo ERCP at a multi-specialty AEC and recover in a post-anesthesia care unit. We assessed the safety of performing ERCP/SOM at an AEC. METHODS: Consecutive pts undergoing SOM over a one-yr period were identified by prospective collection and computer database. All pts had propofol administered by anesthesiology. The standard station pull-through technique was performed using the aspiration manometry catheter. Pts were transferred by ambulance to the hospital 6 miles away for 23hr observation. 30-d complication rate was assessed by clinic/telephone contact and record review. Complications were defined by consensus (CONS) criteria, and by comprehensive (COMP) criteria which included unplanned ER/MD visits, >23 hr observation, or admission for symptoms. SOD was defined by modified Milwaukee criteria. RESULTS: Between 10/02 and 10/03, 595 ERCPs were performed. 53 pts (7M, 46F, mean age 40) underwent 59 SOM procedures providing the cohort for this study. 31 SOMs were biliary, 11 were pancreatic, and 17 were biductal. SOM results: SOD Type II (29), SOD Type III (21), or normal (9). 48 pts had sphincterotomies: 32 biliary, 7 pancreatic, and 15 biductal. 31 pancreatic stents were placed prophylactically. CONS: Total 7 complications (11.9%); 6 pancreatitis, 1 bleed (mild). Pancreatitis severity: 1 mild (SOD III), 2 moderate (SOD II), and 3 severe (2 SOD II, 1 normal). COMP: Total 24 complications (41%) including 13 cases of pain requiring >23hr hospital admission, 1 abdominal pain requiring po analgesics, 1 IV site infiltration, and 2 infection. CONCLUSIONS: 1) SOM can be performed safely in an AEC provided there is on-site anesthesia support and mechanisms for hospital transfer. 2) Our pancreatitis rate is comparable to previously published series. 3) One-fifth of SOM pts without pancreatitis required >23 hr stay for pain management, thus, routine admission post-SOM is recommended. 4) Future studies reporting endoscopy-related complications should incorporate comprehensive criteria as defined for a more accurate assessment of morbidity.