Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy

Evaluation of Preoperative Biliary Drainage on Outcome of Pancreatoduodenectomy: A Multicenter Randomized Controlled Study

The purpose of this study is to evaluate the efficacy of preoperative biliary drainage (PBD) which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by observing the prevalence of drainage and surgery related complications, hospital stay, medical cost and life quality compared to surgery alone. It is anticipated that PBD can reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer; Periampullary Carcinoma
• Intervention / Treatment: Procedure: Pancreatoduodenectomy; Procedure: ENBD and Pancreatoduodenectomy; Procedure: EBD and Pancreatoduodenectomy; Procedure: PTCD and Pancreatoduodenectomy

Detailed Description

Obstructive jaundice is a common symptom in patients with pancreatic head cancer or peri-ampullary cancer. It is regarded that proper surgical resection is the only possible way of radical cure for those patients without evidence of metastasis. Since high preoperative bilirubin level is suggested to be a risk factor for pancreatoduodenectomy, preoperative biliary drainage has been applied to clinical practice to improve the outcome of surgery. However, results from previous studies have inconsistent results showing that PBD may have adverse effect on patients by elevating the prevalence of complications. Since PBD is widely performed worldwide, its value needs to be clarified. Thus the present study is designed to systematically evaluate the value of PBD via recruiting participants who may most likely benefit from PBD. It is anticipated that results from this study can present an instructive conclusion on whether PBD should be performed prior to pancreatoduodenectomy as well as reveal the preferable type of PBD.

• Study Type: Interventional
• Enrollment (Anticipated): 274
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Institution of Hepatobiliary Surgery, Southwest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 to 70 years old
• CT (Computed Tomography), CTA (Computed Tomographic Angiography), MRI (Magnetic Resonance Imaging) or ultrasonic test suggested pancreatic head carcinoma or periampullary carcinoma with obstructive jaundice
• First routine test of serum bilirubin above 250μmol per liter

Exclusion Criteria:

• Distant metastasis in liver, lung or other sites
• Invasion of local blood vessels (e.g. aorta, portal vein, postcava)
• Poor physical condition, unable to tolerate anesthesia and surgery (e.g. severe cardio-pulmonary diseases, blood coagulation disorders)
• With cholangitis, active hepatitis or other diseases which should be excluded from study according to the investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Pancreatoduodenectomy; Instant pancreatoduodenectomy within one week after diagnosis including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract.	Procedure: Pancreatoduodenectomy
EXPERIMENTAL: ENBD and Pancreatoduodenectomy; Consistent ENBD (Endoscopic Nasobiliary Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract.	Procedure: ENBD and Pancreatoduodenectomy
EXPERIMENTAL: EBD and Pancreatoduodenectomy; Consistent EBD (Endoscopic Biliary Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract.	Procedure: EBD and Pancreatoduodenectomy
EXPERIMENTAL: PTCD and Pancreatoduodenectomy; Consistent PTCD (Percutaneous Transhepatic Cholangial Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract.	Procedure: PTCD and Pancreatoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Infectious Complications	up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Life Quality Score	up to 12 months
Incidence of Hemorrhagic Complications	up to 6 months
Liver Function Evaluation	up to 6 months
Incidence of Bile Leakage	up to 6 months
Incidence of Pancreatic Leakage	up to 6 months
Digestive Function Recovery	up to 6 months

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of Incision Complications	up to 3 months
Incidence of Pulmonary Infections	up to 6 months
Incidence of Pleural Effusion	up to 6 months

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (ESTIMATE): September 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 13, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Pancreatoduodenectomy; Obstructive Jaundice; Preoperative Biliary Drainage
• Other Study ID Numbers: NDR-2014-02