Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

NCT04289831

Periampullary Cancer Biliary Obstruction Preoperative Biliary Drainage

COMPLETED NA

Preoperative Biliary Drainage in Malignant Biliary Obstruction

NCT04847297

Pancreatic Cancer

NOT_YET_RECRUITING

Evaluation of A New Digestive Reconstruction Procedure Following Pancreatoduodenectomy

NCT01931449

Pancreatic Cancer Periampullary Carcinoma

UNKNOWN PHASE3

Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy

NCT06322680

Pancreaticoduodenectomy

RECRUITING NA

Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

NCT01744938

Postoperative Complications

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer Periampullary Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Pancreatoduodenectomy

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

ENBD and Pancreatoduodenectomy

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

EBD and Pancreatoduodenectomy

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

PTCD and Pancreatoduodenectomy

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pancreatoduodenectomy

Intervention Type PROCEDURE

ENBD and Pancreatoduodenectomy

Intervention Type PROCEDURE

EBD and Pancreatoduodenectomy

Intervention Type PROCEDURE

PTCD and Pancreatoduodenectomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No