Clinical Trials Logo

Clinical Trial Summary

Patients with obstructive jaundice due to periampullary tumor can temporarily be relieved of their jaundice with transpapillary stenting at endoscopic retrograde cholangio-pancreatography (ERCP) prior to operation. Usually plastic stents are used.

Hypothesis: Self expanding metallic stents offer a be a better alternative for preoperative stenting in patients with obstructive jaundice due to periampullary tumour obstruction.


Clinical Trial Description

Patients who present with obstructive jaundice and have a periampullary tumor and where the patient seems to be in good condition for surgical resection are offered the opportunity to become randomized to either endoscopic drainage with self expanding metallic or plastic stents. Before randomization they are informed about the study details and have to give their consent to participate. The metallic as well as plastic stents are standard commercially available stents. Within four weeks after stent placement the patient will be operated and the following parameters will be evaluated: quality of life, clinical symptoms and lab tests. At the operation the surgeon will make an evaluation of the inflammatory reaction in the area of the bile ducts. A culture from the bile is sampled close to the area where the anastomosis will be sutured. A tissue sample is also taken from the bile ducts to evaluate inflammation. A Lymph node is also sampled for the same reason. The surgeon also evaluates the difficulty with which the stent had to be removed. Postoperative complications are monitored in line with the regular routines at the clinic. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02166840
Study type Interventional
Source Karolinska University Hospital
Contact
Status Completed
Phase Phase 2
Start date March 2007
Completion date January 2015

See also
  Status Clinical Trial Phase
Completed NCT01506115 - Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma N/A
Completed NCT00409864 - Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer N/A
Not yet recruiting NCT06093048 - Endoscopic Retrograde Cholangiopancreatography In Patients Older Than 65Years Old With Obstructive Jaundice: Efficacy And Outcome N/A
Completed NCT02468076 - Radiofrequency Ablation for Biliopancreatic Malignancy Phase 2
Not yet recruiting NCT03491254 - Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ
Recruiting NCT02797665 - Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids N/A
Recruiting NCT01367821 - Immune Function in Patients With Obstructive Jaundice N/A
Recruiting NCT06456476 - Patients With Obstructive Jaundice In Sohag University Hospital
Completed NCT04385147 - Advanced Endoscopy During COVID-19
Completed NCT05155475 - Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-pancreatic Malignancies (ECCO Trial)
Recruiting NCT03133026 - Cholangioscopic Assessment of Occluded Biliary Stent and Role of Biliary Radiofrequency Ablation N/A
Recruiting NCT01438385 - Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders N/A
Completed NCT01191814 - Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression N/A
Recruiting NCT05246176 - Ultrasonography as a Single Tool for Guided Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice N/A
Recruiting NCT03977779 - Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis N/A
Completed NCT04823832 - Endoscopic Versus Percutaneous Biliary Drainage for Resectable Pancreatic Head Cancer N/A
Completed NCT03376945 - Application of n-3 Fatty to Patient of Jaundice N/A
Completed NCT03510754 - Endoscopic Ultrasound-guided Biliary Drainage for Malignant Biliary Obstruction After Failed ERCP
Not yet recruiting NCT01688375 - The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients With Obstructive Jaundice Phase 2
Recruiting NCT05928286 - Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice