Pancreatic Diseases Clinical Trial
Official title:
Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method in Patients With High Risk of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicenter Randomized Controlled Trial
The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an initial procedure for biliary access in patients with biliary disease who are at increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and to assess the incidence rate of complications including PEP between NKF and conventional cannulation methods.
Endoscopic retrograde endoscopic retrograde cholangiopancreatography (ERCP) is widely used for the diagnosis and treatment of pancreatic and biliary tract disease. However, post-ERCP pancreatitis (PEP) is the most common adverse event following the procedure, ranging from 2% to 10% in nonselective cases, and it can cause substantial morbidity, mortality, or high medical costs. Recent advances in cannulation technique and accessories for biliary cannulation have contributed to reduce the incidence of PEP, but biliary cannulation can fail in 5% to 20% of cases of ERCP. Suprapapillary needle-knife fistulotomy (NKF), with or without large-diameter balloon dilation, has been used as a rescue method in cases of difficult biliary cannulation, and NKF was recommended as an initial approach to selective biliary cannulation in cases of repetitive unintentional pancreatic cannulation.9 Moreover, difficult biliary cannulation is known to be a risk factor for PEP, and it has been reported that NKF is associated with a low risk of PEP. Thus, we hypothesized that NKF may reduce the risk of PEP in patients who are at increased risk for PEP. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04205058 -
Coffee After Pancreatic Surgery
|
N/A | |
Completed |
NCT02971579 -
A Register on the Quality of ERCP and Training of Endoscopists in Italy
|
||
Not yet recruiting |
NCT01900938 -
Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP
|
N/A | |
Completed |
NCT01427725 -
Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
|
||
Not yet recruiting |
NCT05954221 -
Red Cell Lysis Buffer Application Versus Conventional Sample Processing in EUS-FNB
|
N/A | |
Enrolling by invitation |
NCT02471170 -
Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases
|
||
Completed |
NCT04705740 -
Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography
|
||
Recruiting |
NCT04259580 -
Calgary Registry for Advanced and Therapeutic Endoscopy
|
||
Recruiting |
NCT04291651 -
UCSF PANC Cyst Registry
|
||
Enrolling by invitation |
NCT03234543 -
Remote Ischemic Conditioning in Abdominal Surgery
|
N/A | |
Completed |
NCT03717298 -
Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma
|
Phase 2 | |
Recruiting |
NCT03334708 -
A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
|
||
Recruiting |
NCT05249400 -
Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training
|
N/A | |
Recruiting |
NCT05824403 -
PAncreatic Disease Cohort of TOuLouse
|
||
Active, not recruiting |
NCT03269994 -
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
|
Phase 3 | |
Enrolling by invitation |
NCT04329039 -
Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
|
Phase 2/Phase 3 | |
Completed |
NCT03198871 -
IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population
|
Phase 4 | |
Completed |
NCT02337673 -
Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography
|
||
Completed |
NCT01964430 -
Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
|
Phase 3 | |
Completed |
NCT02739074 -
Effectiveness of Metal Protheses Covered in "Diabolo" in Treatment of Necrosis of Origin Pancreatic: Trial "DIABOLOPIG"
|