Efficacy of Intra-Ureteric Aminophylline Installation After Failed Stone Accessibility by Semi-rigid Ureteroscopy. Prospective Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAl-Azhar University

About this trial

In this study we will test the effect of local intraureteric aminophylline instillation through Ureteric stent and Reaching stone without the need of ballon dilataion

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The study will include patients with failed stone accessibility by semi-rigid ureteroscopy.

Disqualifiers

Child age group

Pre stented patients

Contraindications to aminophylline (hypersensitivity to drug components, pregnancy or lactation ,…)

Contraindications to ureteroscopy (active urinary tract infection - Contraindications to general or spinal anesthesia - Uncorrected bleeding disorders)

Trial design

Design model

Sequential

Treatments tested in this trial

  • ureteral dilatation

    Procedure/Surgery

    Direct semi-rigid ureteroscopy will initially be attempted without endodilatation (KARL STORZ, 43 cm, 6°, 7 Fr.). On failure to advance the semi-rigid ureteroscope through the ureter, intra-ureteric instillation of 20 ml of aminophylline (250 mg/10 mL) through ureteric stent and another trial to pass the same scope will be done after 10 minutes of intra-ureteral aminophylline instillation.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: The group of patients with failed stone accessibility by semi-rigid ureteroscopyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Success rate of Ureteral access and Scoping of the stones after Intra-ureteral instillation of Aminophylline without Ballon Dilatation

Success rate of Ureteral access and Scoping of the stones after Intra-ureteral instillation of Aminophylline without Ballon Dilatation

Time frame
from the start of ureteroscopy entrance to the end of the procedure

Secondary outcomes

1

Success of complete extraction of stones

Success of complete extraction of stones after intraureteric injection of aminophylline

Time frame
from the start of ureteroscopic entrance to the end of the procedure

Other outcomes

Sponsors and contacts

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