A156 LOW COMPLICATION RATE IN THE OUTPATIENT INTRAJEJUNAL LEVODOPA/CARBIDOPA INTESTINAL GEL CLINICAL PROGRAM. (26th February 2020)

• Record Type: Journal Article
• Authors: Al Yatama, N; Parker, C H; Tse, Y; Naranian, T; Fasano, A; Lang, A; Liu, L W
• Is Part Of: Journal of the Canadian Association of Gastroenterology. Volume 3:Supplement 1(2020)
• Page Start: 20
• Page End: 21
• Publication Date: 2020-02-26
• Subjects: Gastroenterology -- Periodicals; 616.33005
• DOI: 10.1093/jcag/gwz047.155
• Languages: English
• ISSNs: 2515-2084

Abstract

Abstract: Background: Levodopa/carbidopa intestinal gel (LCIG) is a formulation that is delivered continuously through a percutaneous endoscopy gastro-jejunal tube (PEG-J) for the treatment of patients with advanced Parkinson's disease (PD). LCIG significantly reduces periods of increased motor symptoms without troublesome dyskinesia. Adverse events related to this treatment have been attributed to PEG-J insertion and the device used for LCIG delivery, rather than to the LCIG preparation itself. To date, the data evaluating long-term efficacy and safety of PEG-J insertion for LCIG administration in the outpatient setting is limited. Aims: The aim of this study is to describe short and long-term adverse events (AEs) associated with outpatient PEG-J tube insertion for LCIG administration at our centre. Methods: A retrospective chart review was performed of all PD patients who underwent PEG-J insertion for LCIG therapy at Toronto Western Hospital from March 2011 to October 2019. All AEs associated with PEG-J insertion were collected including procedure and tube related complications, hospital admissions, emergency room (ER) visits and deaths. Data was analyzed using descriptive statistics. Results: A total of 58 patients were identified and included in the final analysis. 37 (64%) male, with a mean age of 74 years +/-6.17. The mean duration of PD diagnosis prior to PEG-J insertion was 16.5 years +/-2.0. Mean time from PEG-J insertion to data collection was 37.5 months +/- 19.3. 30 (51%) patients had post-procedural abdominal pain or site pain. This pain improved with over the counter analgesics. 9 (16%) had possible site infection; 6 received oral antibiotics and 3 had the tube replaced. 19 (33%) developed granulation tissue, with only 2 patients requiring tube exchange. 32 (55%) had their tube removed or exchanged secondary to PEG-J malfunction. No ER visits related to the PEG-J were recorded. During the data collection period, 12 (21%) patients died for reasons unrelated to PEG-J insertion. There were no reported serious adverse events (SAEs), including post-procedure perforation, bleeding, fistula formation, development of intra-abdominal collections or buried bumper syndrome. Conclusions: This study demonstrates the absence of serious AEs associated with outpatient PEG-J insertion for LCIG administration in patients with advanced PD. The most common short-term AE was post-procedural pain. The most common long-term AE was related to PEG-J malfunction requiring replacement. This study supports that the current method of outpatient PEG-J insertion for the administration of LCIG is safe in patients with advanced PD. Funding Agencies: None