Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Shaare Zedek Medical Center
With
The research protocol extends for up to 3.5 months, during which the participant will attend 5 clinic visits at Shaare Zedek Medical Centre: screening visit, week 0, week 4, week 8 and week 12. During the screening visit, all patients identified who meet the exclusion and inclusion criteria and who agree to participate in the study, will have their medical records reviewed for previous clinical or biochemical evidence of pancreatitis, both related, and unrelated to thiopurine use. Patients will undergo a physical examination, baseline blood tests including measurement of lipase and/or amylase, liver biochemistry and fasting lipid profile. If not already tested, the patients TPMT activity will be tested. Participants will also have a baseline abdominal ultrasound to confirm normal anatomy and absence of cholelithiasis At week 0, if there are no clinical, biochemicals or ultrasound suggestions of pancreatitis, the participant will be commenced on an alternative thiopurine from what was used in the past. That is, if in the past they were treated with AZA, they will now be commenced on 6-MP, and if in the past they were treated with 6MP, they will be commenced on AZA. The medications will be commenced at standard dose (ie AZA 2.5mg/kg/day, 6MP 1.5mg/kg/day). Depending on the specific situation, and assuming all relevant information is available, the screening visit may be merged with the week 0 visit. In weeks 1, 2, 3 and 6 will have blood tests (full blood count and liver biochemistry) performed at a local clinic, and the investigator will be in telephone contact with the participant to discuss the results and to discuss if there are any adverse effects of the medication. In weeks 4, 8 and 12 the participant will attend clinic with the investigator for a medical history, clinical examination and review of blood tests (blood count and liver enzymes). In the event of any new onset upper abdominal pain or emesis, patients will be instructed to present to their nearest medical facility for blood tests (including serum amylase and/or lipase) and an ultrasound, if clinically indicated, to contact the investigator and to consider cessation of the thiopurine. At the end of the 3 month period, if patients show no sign of pancreatitis, they will revert to regular monitoring of thiopurine therapy as per their treating gastroenterologist.
Age
5–60
Sex
ALL
Healthy volunteers
Not accepted
