Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01941342
• Other study ID #: NDR-2014-02
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 10, 2013
• Last updated: January 13, 2014
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2014
• Source: Southwest Hospital, China
• Contact: Huai-zhi Wang, M.D., Ph.D.
• Phone: 86-23-13996950719
• Email: whuaizhi[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 274
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Periampullary Carcinoma

Intervention

Procedure:
• Pancreatoduodenectomy

• ENBD and Pancreatoduodenectomy

• EBD and Pancreatoduodenectomy

• PTCD and Pancreatoduodenectomy

Locations

Country	Name	City	State
China	Institution of Hepatobiliary Surgery, Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Incision Complications		up to 3 months	Yes
Other	Incidence of Pulmonary Infections		up to 6 months	Yes
Other	Incidence of Pleural Effusion		up to 6 months	Yes
Primary	Incidence of Infectious Complications		up to 12 months	Yes
Secondary	Incidence of Hemorrhagic Complications		up to 6 months	Yes
Secondary	Liver Function Evaluation		up to 6 months	Yes
Secondary	Incidence of Bile Leakage		up to 6 months	Yes
Secondary	Incidence of Pancreatic Leakage		up to 6 months	Yes
Secondary	Life Quality Score		up to 12 months	No
Secondary	Digestive Function Recovery		up to 6 months	Yes