Clinical Trials Logo

Clinical Trial Summary

Patients with potentially resectable pancreatic head cancer and high bilirubin level, were stratified into two equal groups according to the method of biliary drainage: endoscopic stenting or percutaneous drainage.


Clinical Trial Description

Along with history taking and complete clinical examination, the results of complete blood count, international normalized ratio , renal and liver function tests were obtained. Patients with coagulopathy were corrected by fresh frozen plasma and repeated vitamin K injections to reach an INR of at least 1.4 before the intervention, otherwise, they were excluded. Besides, ultrasound and computed tomography of the abdomen/pelvis (pancreatic protocol) were routinely undertaken. Tumors were staged for resectability according to TNM staging system. Patients were randomly divided by closed envelope method into two groups; patients were allocated to the first group (ERCP) who underwent Endoscopic Retrograde Cholangio-Pancreatography coupled with placement of a 10-French plastic stent; and to the second group (PTD) who underwent Fluoroscopy-guided Percutaneous Transhepatic Drainage. Preoperative biliary drainage Parenteral broad spectrum antibiotics were administered prior and after each intervention. ERCP was performed under general anesthesia in the operation room and a 10-french (3.2 mm) covered polyethylene stent with side flaps to prevent migration was placed below the level of biliary bifurcation. Stents were inserted over a guidewire via an Olympus 4.2 mm channel endoscope, by standard techniques. PTD was placed in the interventional radiology department under local anesthesia via the left duct sub-xiphoid approach, only via the external approach. A 6 french gauge catheter was positioned with its tip above the biliary obstruction. After PTD, patients were instructed to drink a lot of fluids to replace fluid loss or they were given temporary intravenous fluid supplementation. After either procedure, patients were either discharged home or kept in hospital. Those who were discharged were readmitted for preoperative preparation. Patients were followed up clinically as well as by laboratory results. The total and direct bilirubin level and other liver function tests were repeated after ten days from the procedure to estimate the decline in their levels. Post-intervention complications either PTD-related such as bleeding, cholangitis, bile leak and catheter occlusion/displacement; or ERCP-related such as pancreatitis, cholangitis, bleeding and stent displacement; were recorded. Surgery After improvement of liver functions, patients were scheduled for PD. All operations were performed through a hockey-stick incision by consultant surgeons experienced in pancreatic surgery. The standard surgical procedure was pancreaticoduodenectomy with pylorus preservation. The effects of pre-operative drainage were evaluated during the operation in terms of operative resection time, blood loss, difficulties of dissection and intra-operative bleeding. While the endoscopic stent is removed intra-operatively after transection of the common hepatic duct, the catheter of PTD is left and inserted in the hepaticojejunostomy (stented anastomosis) to be removed two weeks later. Perioperative complications (< 30 days) were stratified for each group according to Clavien-Dindo classification. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04823832
Study type Interventional
Source Alexandria University
Contact
Status Completed
Phase N/A
Start date January 1, 2019
Completion date December 31, 2020

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 NCT02166840 - Metal or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors. Phase 2
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 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