A randomized controlled trial of Bupropion on Nicotine Dependence and Positive and Negative symptoms amongst patients suffering from schizophrenia attending the out-patient department of a tertiary care centre

Abstract Background Social anxiety (SA), a prevalent comorbid condition in psychotic disorders with a negative impact on functioning, requires adequate intervention relatively early. Using a randomized controlled trial, we tested the efficacy of a group cognitive-behavioral therapy intervention for SA (CBT-SA) that we developed for youth who experienced the first episode of psychosis (FEP). For our primary outcome, we hypothesized that compared to the active control of group cognitive remediation (CR), the CBT-SA group would show a reduction in SA that would be maintained at 3- and 6-month follow-ups. For secondary outcomes, it was hypothesized that the CBT-SA group would show a reduction of positive and negative symptoms and improvements in recovery and functioning. Method Ninety-six patients with an FEP and SA, recruited from five different FEP programs in the Montreal area, were randomized to 13 weekly group sessions of either CBT-SA or CR intervention. Results Linear mixed models revealed that multiple measures of SA significantly reduced over time, but with no significant group differences. Positive and negative symptoms, as well as functioning improved over time, with negative symptoms and functioning exhibiting a greater reduction in the CBT-SA group. Conclusions While SA decreased over time with both interventions, a positive effect of the CBT-SA intervention on measures of negative symptoms, functioning, and self-reported recovery at follow-up suggests that our intervention had a positive effect that extended beyond symptoms specific to SA. ClinicalTrials.gov identifier: NCT02294409.

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Fistulotomy versus standard cannulation as the primary technique for all patients undergoing ERCP with a native papilla: A protocol for a single centre randomized controlled trial

10.21203/rs.3.rs-537086/v1 ◽

2021 ◽

Author(s):

Lawrence Hookey ◽

Mandip Rai ◽

Robert Bechara

Keyword(s):

Randomized Controlled Trial ◽

Bile Duct ◽

Patient Population ◽

Controlled Trial ◽

Tertiary Care ◽

Efficacy And Safety ◽

Tertiary Care Centre ◽

Successful Cannulation ◽

Randomized Controlled ◽

Needle Knife

Abstract Background Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable procedure for the management of pancreaticobiliary diseases. Post-ERCP pancreatitis (PEP) is the most common serious adverse event. One risk factor of PEP is difficulty achieving biliary access. The conventional ERCP technique involves the cannulation of the bile duct via the ampulla of Vater, followed by sphincter incision using electrocautery. Conventionally if the standard method fails then precut techniques have been utilized as an alternative means of gaining biliary access. The needle-knife fistulotomy (NKF) technique involves identifying the intra-duodenal segment of the bile duct and uses a needle knife to incise directly into the bile duct. This is done above and away from the natural office, thus minimizing thermal damage which may result in PEP. Our recent prospective study of 50 patients demonstrated the safety and feasibility of the NKF precut technique as a primary means of gaining biliary access. The next step is to conduct a randomized-controlled trial to compare the efficacy and safety of initial NKF to the standard cannulation in a non-selective patient population undergoing ERCP.Methods A randomized control trial of 538 consecutive, non-selective patients with pancreatoticobiliary disease undergoing ERCP at a tertiary care centre in Kingston, Ontario, Canada will be conducted. Patients will be randomized to one of two treatment groups, standard cannulation or NKF. The primary outcome of the study will be the incidence of PEP. Secondary outcomes will include rate of successful cannulation of the CBD, time to successful cannulation, total procedure time, difficulty of cannulation and incidence of complications. Discussion This RCT will yield important answers regarding the efficacy and safety of initial NKF to the standard cannulaton in a non-selective patient population undergoing ERCP. The results of our study could alter ERCP practices and outcomes if NKF is shown to reduce PEP risk.Trial Registration This trial was registered on clinicaltrials.gov (NCT04559867) on September 23, 2020. https://clinicaltrials.gov/ct2/show/NCT04559867?term=bechara&draw=2&rank=2

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