Pancreatic CancerPhase 2NCT01941342
Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy
A Phase 2 study testing Pancreatoduodenectomy, ENBD and Pancreatoduodenectomy and EBD and Pancreatoduodenectomy in people with Pancreatic Cancer and Periampullary Carcinoma, run by Southwest Hospital, China at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer, Periampullary Carcinoma
- What is being tested?
- Pancreatoduodenectomy, ENBD and Pancreatoduodenectomy and EBD and Pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Institution of Hepatobiliary Surgery, Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Liang-yu Yin, M.D., 86-23-13937975651, liangyuyin1988@gmail.com
Huai-zhi Wang, M.D., Ph.D
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cancer, Periampullary Carcinoma
- Being tested
- Pancreatoduodenectomy, ENBD and Pancreatoduodenectomy, EBD and Pancreatoduodenectomy, PTCD and Pancreatoduodenectomy
- Keywords
- Obstructive Jaundice, Preoperative Biliary Drainage, Pancreatoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreatoduodenectomyProcedure or surgery
ENBD and PancreatoduodenectomyProcedure or surgery
EBD and PancreatoduodenectomyProcedure or surgery
PTCD and PancreatoduodenectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: PTCD and Pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Infectious Complications
Measured: up to 12 months
Secondary outcomes (6)
Incidence of Hemorrhagic Complications
Measured: up to 6 months
Liver Function Evaluation
Measured: up to 6 months
Incidence of Bile Leakage
Measured: up to 6 months
Incidence of Pancreatic Leakage
Measured: up to 6 months
Life Quality Score
Measured: up to 12 months
Digestive Function Recovery
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huai-zhi Wang, Southwest Hospital, China
- Investigators
- Huai-zhi Wang, M.D., Ph.D., Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941342
- Sponsor's protocol ID
- NDR-2014-02
- Status last verified
- Jan 2014
- First submitted
- 10 Sep 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preoperative Biliary Drainage on Outcome of Pancreatoduodenectomy: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01941342
- Acronym / sponsor ID
- NDR-2014-02
- Conditions
- Pancreatic Cancer, Periampullary Carcinoma
- Keywords
- Obstructive Jaundice, Preoperative Biliary Drainage, Pancreatoduodenectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pancreatoduodenectomy | Active comparator | Procedure: PancreatoduodenectomyInstant 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 | Procedure: ENBD and PancreatoduodenectomyConsistent 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 | Procedure: EBD and PancreatoduodenectomyConsistent 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 | Procedure: PTCD and PancreatoduodenectomyConsistent 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatoduodenectomy | Procedure or surgery | Pancreatoduodenectomy |
| ENBD and Pancreatoduodenectomy | Procedure or surgery | ENBD and Pancreatoduodenectomy |
| EBD and Pancreatoduodenectomy | Procedure or surgery | EBD and Pancreatoduodenectomy |
| PTCD and Pancreatoduodenectomy | Procedure or surgery | PTCD and Pancreatoduodenectomy |
Primary outcome
Incidence of Infectious Complications
Time frame: up to 12 months
6 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huai-zhi Wang, M.D., Ph.D. principal investigator
Southwest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pancreatoduodenectomy, ENBD and Pancreatoduodenectomy and EBD and Pancreatoduodenectomy in people with Pancreatic Cancer and Periampullary Carcinoma, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huai-zhi Wang, M.D., Ph.D. (86-23-13996950719, whuaizhi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Infectious Complications (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.