Endoscopic Versus Percutaneous Biliary Drainage for Resectable Pancreatic Head Cancer
Condition: Pancreatic Head Cancer; Obstructive Jaundice
MeSH terms: Head and Neck Neoplasms; Jaundice; Jaundice, Obstructive
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): pancreaticoduodenectomy
Intervention type(s): Procedure
Intervention description(s): resection of the head of pancreas and the duodenum followed by triple anastomosis
Other intervention name(s): whipple operation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment