Periampullary CancerNCT01789502
Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage
A study testing Fully covered metal stents and Plastic stents in people with Periampullary Cancer and Complications of Surgical Procedures or Medical Care, run by Inje University at 3 sites in South Korea.
Trial summary
This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Periampullary Cancer, Complications of Surgical Procedures or Medical Care, Disorder of Bile Duct Stent
- What is being tested?
- Fully covered metal stents and Plastic stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jan 2012to Feb 2015
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 20 years old of age
- Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary cancer
- No evidence of distant metastases or locally advanced tumor
Who cannot join
- Unresectable stage of cancer
- Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis)
- Severe gastric outlet obstruction or duodenal obstruction
- Severe comorbidity (Karnofsky<50%)
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Daejun Eulji University Hospital
Daejun, Daejun, 302-799
Inje University Ilsan Paik Hospital
Koyang, Gyeonggi-do, 411-706
Asan Medical Center
Seoul, Seoul, 138-736
About this study
Official title: Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?
This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.
Read the detailed description
Pancreaticoduodenectomy is curative option in periampullary tumor. Preoperative endoscopic retrograde cholangiopancreatog-raphy (ERCP) is usually undertaken in patients with resectable disease to relieve biliary obstruction, which is thought to impair immune response, clotting, and other functions that impact intraoperative and postoperative outcomes. Despite conflicting data pertaining to preoperative biliary drainage, ERCP with biliary stenting has become standard practice in patients with periampullary malignancies. In a recent multicenter randomized trial, patients who underwent preoperative biliary drainage had a 74% rate of complications compared with 39% for those who directly underwent surgery without preoperative biliary drainage. In this trial, however, all patients underwent placement of plastic stents. In ERCP, self-expandable metal stent are being increasingly placed for palliation of malignant biliary obstruction. Compared with plastic stents, self-expandable metal stents have large caliber and have demonstrated longer patency duration. Even in patients with resectable malignant disease, self-expandable metal stents which are placed below the level of transection may not impair technical outcomes at surgery and can be safely removed along with the surgical specimen.
This prospective study is designed to compare the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays in patients with periamupllary tumors who are undergone with self-expandable metal stents or plastic stents placement for preoperative biliary drainage
- Conditions
- Periampullary Cancer, Complications of Surgical Procedures or Medical Care, Disorder of Bile Duct Stent
- Being tested
- Fully covered metal stents, Plastic stents
- Keywords
- self-expandable metal stent; plastic stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully covered metal stentsDevice
Also called BONASTENT, Standard Sci Tech, Seoul, Korea
Fully covered metal stents were inserted by ERCP
Plastic stentsDevice
Also called Biliary stents, Cook Endoscopy, Winston-Salem, NC
Plastic stents were inserted by ERCP
| Study group | Role | What they receive |
|---|---|---|
| Plastic stents | Active comparator | Plastic stents are inserted by ERCP Receives: Device: Plastic stents |
| Fully covered metal stents | Experimental | Fully covered metal stents are inserted by ERCP Receives: Device: Fully covered metal stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to the stent insertion
Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage.
Measured: up to 4weeks
Secondary outcomes (3)
Re-intervention rate
Re-intervention is defined as endoscopic retrograde cholangiopancreatography or percutaneous transhepatic biliary drainage procedures which are required to achieve adequate preoperative biliary drainage after stent insertion.
Measured: up to 4weeks
Hospital stay
Hospital stay is defined as the period between the date of stent insertion and that of discharge.
Measured: up to 1months
Surgical outcomes
Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery.
Measured: up to 1months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periampullary 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tea Jun Song, Inje University
- Investigators
- Tae Jun Song, MD, PhD, Principal investigator, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789502
- Sponsor's protocol ID
- IB-1210-034
- Status last verified
- Aug 2015
- First submitted
- 5 Feb 2013
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Song TJ, Lee JH, Lee SS, Jang JW, Kim JW, Ok TJ, Oh DW, Park DH, Seo DW, Lee SK, Kim MH, Kim SC, Kim CN, Yun SC. Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection. Gastrointest Endosc. 2016 Nov;84(5):814-821. doi: 10.1016/j.gie.2016.04.018. Epub 2016 Apr 22.
PubMed 27109456
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?
- ClinicalTrials.gov ID
- NCT01789502
- Acronym / sponsor ID
- IB-1210-034
- Conditions
- Periampullary Cancer, Complications of Surgical Procedures or Medical Care, Disorder of Bile Duct Stent
- Keywords
- self-expandable metal stent; plastic stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Feb 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.
This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.
Detailed description
Pancreaticoduodenectomy is curative option in periampullary tumor. Preoperative endoscopic retrograde cholangiopancreatog-raphy (ERCP) is usually undertaken in patients with resectable disease to relieve biliary obstruction, which is thought to impair immune response, clotting, and other functions that impact intraoperative and postoperative outcomes. Despite conflicting data pertaining to preoperative biliary drainage, ERCP with biliary stenting has become standard practice in patients with periampullary malignancies. In a recent multicenter randomized trial, patients who underwent preoperative biliary drainage had a 74% rate of complications compared with 39% for those who directly underwent surgery without preoperative biliary drainage. In this trial, however, all patients underwent placement of plastic stents. In ERCP, self-expandable metal stent are being increasingly placed for palliation of malignant biliary obstruction. Compared with plastic stents, self-expandable metal stents have large caliber and have demonstrated longer patency duration. Even in patients with resectable malignant disease, self-expandable metal stents which are placed below the level of transection may not impair technical outcomes at surgery and can be safely removed along with the surgical specimen.
This prospective study is designed to compare the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays in patients with periamupllary tumors who are undergone with self-expandable metal stents or plastic stents placement for preoperative biliary drainage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plastic stents | Active comparator | Device: Plastic stentsPlastic stents are inserted by ERCP |
| Fully covered metal stents | Experimental | Device: Fully covered metal stentsFully covered metal stents are inserted by ERCP |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 20 years old of age
- Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary cancer
- No evidence of distant metastases or locally advanced tumor
Key exclusion criteria (4 listed)
- Unresectable stage of cancer
- Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis)
- Severe gastric outlet obstruction or duodenal obstruction
- Severe comorbidity (Karnofsky<50%)
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 |
|---|---|---|
| Fully covered metal stentsAlso: BONASTENT, Standard Sci Tech, Seoul, KoreaFully covered metal stents were inserted by ERCP | Device | Fully covered metal stents |
| Plastic stentsAlso: Biliary stents, Cook Endoscopy, Winston-Salem, NCPlastic stents were inserted by ERCP | Device | Plastic stents |
Primary outcome
Adverse events related to the stent insertion
Time frame: up to 4weeks
Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage.
3 secondary outcomes
Re-intervention rate
Time frame: up to 4weeks
Hospital stay
Time frame: up to 1months
Surgical outcomes
Time frame: up to 1months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Derived from this study: PubMed 27109456Song TJ, Lee JH, Lee SS, Jang JW, Kim JW, Ok TJ, Oh DW, Park DH, Seo DW, Lee SK, Kim MH, Kim SC, Kim CN, Yun SC. Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection. Gastrointest Endosc. 2016 Nov;84(5):814-821. doi: 10.1016/j.gie.2016.04.018. Epub 2016 Apr 22.
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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.
Tae Jun Song, MD, PhD principal investigator
Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully covered metal stents and Plastic stents in people with Periampullary Cancer and Complications of Surgical Procedures or Medical Care, run by Inje University at 3 sites in South Korea.
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: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events related to the stent insertion (time frame: up to 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01789502, which also lists 1 linked publication.
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 4 Aug 2015.