A156 LOW COMPLICATION RATE IN THE OUTPATIENT INTRAJEJUNAL LEVODOPA/CARBIDOPA INTESTINAL GEL CLINICAL PROGRAM
Bibliographic record
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
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".