---
title: Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy
nct_id: NCT01941342
overall_status: UNKNOWN
phase: PHASE2
sponsor: Southwest Hospital, China
study_type: INTERVENTIONAL
primary_condition: Pancreatic Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01941342.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01941342"
ct_last_update_post_date: 2014-01-14
last_seen_at: "2026-05-12T07:04:02.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy

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

**NCT ID:** [NCT01941342](https://clinicaltrials.gov/study/NCT01941342)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 274
- **Lead Sponsor:** Southwest Hospital, China
- **Conditions:** Pancreatic Cancer, Periampullary Carcinoma
- **Start Date:** 2014-01
- **Completion Date:** 2015-06
- **CT.gov Last Update:** 2014-01-14

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.
- **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.
- **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.
- **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.

## Interventions

- **Pancreatoduodenectomy** (PROCEDURE)
- **ENBD and Pancreatoduodenectomy** (PROCEDURE)
- **EBD and Pancreatoduodenectomy** (PROCEDURE)
- **PTCD and Pancreatoduodenectomy** (PROCEDURE)

## Primary Outcomes

- **Incidence of Infectious Complications** _(time frame: up to 12 months)_

## Secondary Outcomes

- **Incidence of Hemorrhagic Complications** _(time frame: up to 6 months)_
- **Liver Function Evaluation** _(time frame: up to 6 months)_
- **Incidence of Bile Leakage** _(time frame: up to 6 months)_
- **Incidence of Pancreatic Leakage** _(time frame: up to 6 months)_
- **Life Quality Score** _(time frame: up to 12 months)_
- **Digestive Function Recovery** _(time frame: up to 6 months)_

## Locations (1)

- Institution of Hepatobiliary Surgery, Southwest Hospital, Chongqing, Chongqing Municipality, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.institution of hepatobiliary surgery, southwest hospital|chongqing|chongqing municipality|china` — added _(2026-05-12)_

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