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Search / Trial NCT04671095

Single Use ERCP Performance -SURE Study

Launched by NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST · Dec 10, 2020

Trial Information

Current as of July 21, 2025

Completed

Keywords

Exalt Single Use Duodenoscope Ercp

ClinConnect Summary

ERCP is a therapeutic endoscopic procedure done to establish either bile duct or pancreatic duct drainage or both. The indications for ERCP are bile duct stones, bile duct strictures, sphincter of Oddi manometry with sphincterotomy, bile leak, pancreatic duct stones and pancreatic duct stricture. The intended benefits of the procedure are either to relieve bile duct/ pancreatic duct obstruction or facilitate bile duct/ pancreatic duct drainage. It is a minimally invasive procedure and is associated with reduced morbidity compared to surgery.

Gall stones are made of cholesterol, pigment and...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • Patients who are at high risk of post ERCP infection such as
  • Jaundice (Bilirubin \>21)
  • Primary sclerosing cholangitis
  • Post liver transplant anastomotic stricture
  • Inpatients
  • Combined procedures (Ex: ERCP+ spy glass cholangioscopy)
  • Previous inadequate biliary drainage.
  • Biliary stricture
  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Grade 1-3 ERCP on complexity grading (ASGE grading)
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
  • Exclusion Criteria:
  • Patients with CBD stones and no jaundice
  • Sphincter of Oddi manometry.
  • Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
  • Patients who are unable to consent for the study.
  • ERCP for Pancreatic pathology.
  • Grade 4 complex ERCP (ASGE grading)
  • Participant who is terminally ill /ECOG 4
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

About Nottingham University Hospitals Nhs Trust

Nottingham University Hospitals NHS Trust is a leading healthcare provider in the UK, dedicated to delivering high-quality patient care and advancing medical research. Comprising two major hospitals, Queen's Medical Centre and Nottingham City Hospital, the Trust is at the forefront of clinical innovation and education. With a strong emphasis on translational research, Nottingham University Hospitals NHS Trust actively sponsors clinical trials aimed at improving treatment outcomes and understanding various health conditions. The Trust collaborates with academic institutions, healthcare professionals, and industry partners to foster a robust research environment that enhances clinical practice and contributes to evidence-based medicine.

Locations

Nottingham, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Suresh Vasan Venkatachalapathy, MRCP

Principal Investigator

Nottingham University Hospitals NHS Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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