Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy

NCT01941342 | Unknown Phase 2 DMC

• 1 other identifier: NDR-2014-02
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Periampullary Carcinoma

Keywords

Obstructive Jaundice; Preoperative Biliary Drainage; Pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of Infectious Complications

  up to 12 months

Secondary Outcomes (6)

• 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

• Life Quality Score

  up to 12 months

Other Outcomes (3)

• Incidence of Incision Complications

  up to 3 months

• Incidence of Pulmonary Infections

  up to 6 months

• Incidence of Pleural Effusion

  up to 6 months

Study Arms (4)

Pancreatoduodenectomy

ACTIVE COMPARATOR

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

ENBD and Pancreatoduodenectomy

EXPERIMENTAL

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

EBD and Pancreatoduodenectomy

EXPERIMENTAL

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

PTCD and Pancreatoduodenectomy

EXPERIMENTAL

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

Interventions

Pancreatoduodenectomy PROCEDURE

Pancreatoduodenectomy

ENBD and Pancreatoduodenectomy PROCEDURE

ENBD and Pancreatoduodenectomy

EBD and Pancreatoduodenectomy PROCEDURE

EBD and Pancreatoduodenectomy

PTCD and Pancreatoduodenectomy PROCEDURE

PTCD and Pancreatoduodenectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Institution of Hepatobiliary Surgery, Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Jaundice, Obstructive

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Huai-zhi Wang, M.D., Ph.D.

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huai-zhi Wang, M.D., Ph.D.

CONTACT

86-23-13996950719; whuaizhi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

CN (1)