6996 Measuring sustained responses to treatment provided in patients suspected of sphincter of oddi dysfunction (sod): a qa:qi project.

Abstract

Intro: The published response to diagnosis and endoscopic therapy (Dx&ERx) in SOD varies greatly. We measured patients (PTs) reported improvement as a QA:QI project. Hypothesis: A Care Provider,A or B (CPA or CPB) could obtain at least a 60% improvement in the frequency and severity of the presenting symptom, ie pain, in patients that completed the SOD evaluation. Successful outcome was defined as a 60% decrease in pain. Design: Over 18 mo., 81 PTs with presumed SOD were seen. The index CPA or CPB directed all subsequent Dx&ERx. PTs were called after >5mo. post Dx&ERx by a study RN. Predetermined questions were used. CPA also included persistent nausea associated with abnormal serum liver/pancreas tests as an SOD criteria. CPB only used recurrent pain. Responses to Dx&ERx were based on the intent to treat only. CPA used general anesthesia or midazolam+meperidine(1mg/kg bw) for the sedation. CPB used only midazolam & diazepam. Provocative testing during the SO manometry(SOM) included CCK and amyl nitrite(AN). Patients with AN SO relaxation (2/39)were rx'd with arginine or nitrites and not sphincterotomy (ERS) by CPB. CPA used ERS only. A visual analogue pain scale (0- 10) was used. The #pills/mo. was the other indicator of pain severity. The RN could not interview 13 PTs. Outcome: The CPs felt more PTs were improved than the study data suggests, clinic notes suggesting that for CPA 9/19(47%) and for CPB 19/25(76%) improved. Based on the study design the percent improved is less than predicted. Three PTs died during this period: 1 procedure related, 1 malignancy and 1 progressive liver failure. PTs with prior reported ERS or with both panc+biliary SOD(not isolated biliary SOD) were included here. This may have affected the results. ALL sources for pain were addressed in this protocol as SOD evaluations are not a sole end point for upper abdominal pain events. Summary: 1) PTs evaluated for SOD can be an inhomogenous population. 2) Complete pain relief does occur, but the % improved can vary greatly. 3) Each provider must monitor their own responses to offer informed consent.