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NCT04062617: C-ERCP
Cmplications of ERCP
trial in Complication of ERCP in 929 participants. Completed in 1 March 2020.
30 August 2019
Quick facts
| Lead sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 929 |
| Start date | 1 August 2018 |
| Primary completion | 30 August 2019 |
| Estimated completion | 1 March 2020 |
| Sites | 1 location across India |
Conditions studied
- Complication of ERCP — all drugs for Complication of ERCP →
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Who can join
12 and older, any sex, with Complication of ERCP. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Endoscopic retrograde cholangiopancreatography (ERCP) is a form of endoscopy where a Side-viewing endoscope is introduced into the duodenum, following which instruments are passed into bile or pancreatic ducts, to allow their radiological visualisation by injecting contrast medium and/or perform various therapeutic procedures, e.g., removal of bile duct stone. It is a complex endoscopic procedure with long learning curve and has number of complications which can even be life-threatening. Since its introduction in 1968, ERCP has become a widely used endoscopic procedure for a variety of disorders. Endoscopic biliary sphincterotomy was first reported in 1974. ERCP at its inception was predominantly a diagnostic procedure, however over the past decade its predominantly carried out for therapeutic indications because of the availability of other imaging techniques, such as abdominal Ultrasound (US), Computed Tomography (CT), Magnetic resonance cholangiopancreatography (MRCP), Endoscopic Ultrasound (EUS) that provide detailed diagnostic information and thus allowing appropriate selection of patients for therapeutic ERCP. Complications are expected to occur in a proportion of patients undergoing ERCP, even when performed by endoscopists with significant expertise in the procedure. A number of patient-related and technique-related factors are known to increase the risk of complication. ERCP requires sedation and therefore has in addition a risk of anaesthesia related adverse events. Most of the complications post-ERCP are apparent during the first 6 hours after the procedure. There are no large scale study evaluating the complications of ERCP in Indian or even Asian population. In an attempt to address this deficit we will be conducting a dual centre prospective study to look at the incidence of various ERCP-related complications. Proposed study will be done in both a tertiary care public academic centre and a tertiarycare private hospital. Both have specialised and well equipped department to carry out ERCP procedures and evaluate and manage complications if any.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04062617 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Post Graduate Institute of Medical Education and Research, Chandigarh
- Last refreshed: 27 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04062617.
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