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ERCP clinical trials

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NCT ID: NCT05603702 Recruiting - Chronic Pain Clinical Trials

STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis

STTEPP
Start date: March 17, 2023
Phase: Phase 1
Study type: Interventional

The investigators propose to conduct a dose-escalation trial of an FDA-approved antiepileptic drug, lacosamide, added to opioid therapy in patients with chronic abdominal pain from chronic pancreatitis (CP). This pilot trial will test the feasibility of the study design and provide reassurance regarding the tolerability and safety of lacosamide used concomitantly with opioids in this patient population to reduce the condition known clinically as opioid-induced hyperalgesia (OIH).

NCT ID: NCT05225909 Not yet recruiting - Infection Clinical Trials

aScope Single Use ERCP Study- ASSURE Study

ASSURE
Start date: April 1, 2022
Phase:
Study type: Observational

Patients undergo ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as common bile duct (CBD)stones, bile duct obstruction secondary to bile duct narrowing (Strictures) and for bile leak. The incidence of infection post-ERCP is around one in 200. There are some group of patients where this risk is significantly increased. In this high risk group, the risk increases from 1 in 75 to in some diseases 1 in 15 (Described in PIS). There are some reports that some of the infection may be contributed by contamination of bacteria in the scope. This happens even after diligently sterilizing the scope. A multi-centre study reported that the risk of contamination is as high as 39% but what we do not know is how many resulted in bacterial infection. The investigators do not know what percentage of infection is secondary to the above. The new single use duodenoscope (aScope, Ambu Ltd) has been introduced in to the market to minimise the risk of post ERCP infection. It is CE marked but the evidence for performance of the aScope is limited. The investigators want to assess the performance of the scope simultaneously in multiple different hospitals. In addition, the investigators also want to assess the cost consequence to the NHS for using the above scope. Hence, the investigators want to assess the performance of the scope in the high risk groups for infection.

NCT ID: NCT05220774 Completed - ERCP Clinical Trials

Conscious Sedation Versus Anesthesia for ERCP

Start date: October 1, 2018
Phase:
Study type: Observational

Studies directly comparing EDCS with AAS during ERCP are scarce, varying widely in their designs and reaching conflicting conclusions regarding safety and effectiveness. The investigators will assess, via a multi-center prospective study, the success, adverse event rates, and patient tolerability of ERCP when performed under AAS versus EDCS.

NCT ID: NCT05219123 Recruiting - ERCP Clinical Trials

Guidewire Management in ERCP

Start date: December 20, 2021
Phase:
Study type: Observational

Intra-procedural guidewire management is a parameter whose impact remains incompletely understood in terms of its association with post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Inadvertent guidewire cannulation of the pancreatic duct (PD) when attempting common bile duct (CBD) cannulation is recognized as a risk factor for PEP. However, to date, no studies have assessed whether a single PD wire cannulation is associated with a higher PEP risk compared to no PD cannulations. Similarly, the relationship between each additional PD cannulation and the incremental magnitude of PEP risk remains unclear. In this study, the investigators will aim to assess whether a single inadvertent PD cannulation (versus no PD cannulation) is associated with an increased risk of PEP (the primary outcome).

NCT ID: NCT05211206 Recruiting - ERCP Clinical Trials

IV Fluids and Post-ERCP Pancreatitis

Start date: January 10, 2022
Phase:
Study type: Observational

Aggressive intravenous hydration has been shown in randomized trials to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), though studied regimens are often impractical. To date, no studies have prospectively assessed short-term (60-90 minute) aggressive hydration regimens that are feasible for outpatients undergoing ERCP and subsequent discharge. Furthermore, little is known with regard to fluid type, volume, and timing with respect to ERCP. In this study, we will aim to assess whether the amount of peri-procedural intravenous fluid administered around the time of ERCP is associated with the risk of PEP (the primary outcome).

NCT ID: NCT04671095 Completed - Infection Clinical Trials

Single Use ERCP Performance -SURE Study

SURE
Start date: March 9, 2021
Phase:
Study type: Observational

We do ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as bile duct stones, bile duct obstruction secondary to bile duct narrowing (Strictures) and for bile leak. The incidence of infection post ERCP is around one in 200. There are some group of patients where this risk is significantly increased. In this high risk group, the risk increases from 1 in 75 to in some diseases 1 in 15 (Described in PIS). There are some reports that some of the infection may be contributed by contamination of bacteria in the scope. This happens even after diligently sterilizing the scope. A multi-centre study reported that the risk of contamination is as high as 39% but what we do not know is how many resulted in bacterial infection. We do not know what percentage of infection is secondary to the above. The new single use duodenoscope has been introduced in to the market to minimise the risk of post ERCP infection. It is CE marked and a single centre study reported that the above performance of the above scope was comparable to the standard reusable scope. We want to assess the scope simultaneously in multiple different hospitals. In addition, we also want to assess the cost consequence to the NHS for using the above scope. Hence we want to assess the performance of the scope in the high risk groups for infection.

NCT ID: NCT04661332 Recruiting - ERCP Clinical Trials

Registry of Endoscopic Retrograde Cholangiopancreatographies Performed in Humans

ERCP
Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

Treatment of the pathology of the extrahepatic biliary tract is the most frequent indication for performing endoscopic retrograde cholangiography (ERCP). The method, which combines endoscopic and radiological vision, also allows for therapeutic (and diagnostic) procedures on some pathologies of the pancreas and the papilla of Vater. During the maneuvers it is also possible to obtain cyto-histological material for the diagnosis of any lesions identified, through the execution of brushing. The endoscope used for ERCP allows for microsurgical procedures to be performed on the papilla of Vater, on the biliary tract and on the pancreas, procedures that in the past required a real surgical intervention. ERCP is a generally well tolerated procedure, but as with all medical procedures it can have limitations and be followed by some complications. In 5% of cases, the procedure may not be completed due to anatomical variants that do not allow the endoscope to reach the duodenum or to cannulate and visualize the bile and / or pancreatic ducts. The most frequent complication is acute pancreatitis, which can arise as a consequence of surgery on the common outlet of the biliary and pancreatic tracts; it occurs in 3-5% of cases and to date, it cannot be predicted or prevented in all cases. In some groups of patients (young, with non-dilated biliary tract, or with a history of previous pancreatitis) the risk of pancreatitis can reach 10-12% . In rare cases (less than 1%), pancreatitis can have a severe course and may require surgery. Other less frequent complications (with an overall incidence of less than 2%) are: infection of the biliary tract or cystic collections, bleeding resulting from papillo-sphincterotomy, and perforation of the duodenum or ducts. Infection and bleeding are generally treated medically or endoscopically; the perforation may require surgery in some cases. This registry aims to collect in a prospective and / or retrospective way the data of the ERCP procedures performed in our center by evaluating the sex, age of the patient, the reason why the patient was subjected to the examination, diagnosis, clinical risk factors and technical risk (i.e. associated with the procedure itself), if there have been complications, the type of instrumentation in use in our operating unit and / or the operators performing the examinations.

NCT ID: NCT04658212 Not yet recruiting - Choledocholithiasis Clinical Trials

A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The incidence of choledocholithiasis is gradually rising with the increase of gallstone incidence. The popular minimally invasive treatment options include endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic common bile duct exploration (LCBDE). Currently, three-dimensional (3D) video system for laparoscopy is developed to ofer surgeon a superior depth perception and a much better user experience, thus potential increasing operation accuracy and stability. It have suggested that compared with 2D laparoscopy, 3D laparoscopy can effectively reduce operation time and numbers of errors. However, rare experimental studies are performed to evaluate the safety and effectiveness of 3D laparoscopy in choledocholithiasis patients. The aim of this study is to compare the perioperative outcomes between 3D laparoscopy and ERCP in choledocholithiasis patients through a multicenter randomized controlled design.

NCT ID: NCT04619511 Completed - Clinical trials for Chronic Pancreatitis

Risk Factors for Post-ESWL and Post-ERCP Pancreatitis

Start date: October 31, 2016
Phase:
Study type: Observational

The study aimed to identify risk factors for post-ERCP pancreatitis(PEP) after ESWL, and the relationship between the occurrence of post-ESWL pancreatitis and PEP.

NCT ID: NCT04447976 Recruiting - ERCP Clinical Trials

Prospective Evaluation of Performance of Disposable Elevator Cap Duodenoscope During ERCP in Clinical Practice

deCAP
Start date: June 2, 2020
Phase:
Study type: Observational

Purpose: To evaluate overall performance of disposable TIP duodenoscopes and get insight from end-users regarding its performance during various steps of ERCP procedure as well as ease and feasibility of pre-procedure duodenoscope set up and post procedure manual cleaning as well as reprocessing. Research design: This is a prospective observational multi-center study. Procedure used: During ERCP Risks and potential benefits: There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future. Importance of knowledge that may reasonably be expected to result: The quality of health care which will be crucial to identify patterns of competence and identify areas of continued improvement. More specifically in the quality metrics sector we will be able to see what is already in place and steps we will undertake that will be beneficial for physicians.