JaundiceNCT02787512
Preoperative Biliary Drainage With Metal Versus Plastic Stents in Periampullary Cancer
A study testing Stent in people with Jaundice and Periampullary Cancer, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Currently, routine preoperative biliary drainage (PBD) was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Jaundice, Periampullary Cancer
- What is being tested?
- Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jun 2016to 10 Jan 2019
- 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
- Patients 20-80 years old B. Patients with surgically resectable periampullary cancer on CT scans with or without MRI or PET-CT scans C. ECOG Performance score 0 or 1 D. Patients who need preoperative biliary drainage (PBD) because of one or more of following causes
- Cholangitis defined as revised Tokyo guidelines
- Level of total bilirubin >= 10mg/dL
- Expected time to operation >= 7 days
Who cannot join
- Patients who received previous endoscopic biliary drainage or percutaneous biliary drainage B. Patients with acute pancreatitis before PBD
- Patients with bleeding tendency or coagulopathy or anticoagulation therapy as follows:
- Patients who take clopidogrel within 5 days before PBD
- Patients who take warfarin within 2 days before PBD
- Patients who receive heparin within 1 days before PBD D. Patients with pregnancy or suspected pregnancy E. Patients who are currently enrolled in another investigational trials that would directly interfere with current study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Gachon University Gil Medical Center
Incheon
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: A Randomized Controlled Trial for Preoperative Biliary Drainage With Metal Versus Plastic Stents in Patients With Periampullary Cancer
Currently, routine preoperative biliary drainage (PBD) was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery.
The aim of this clinical trial is to demonstrate non-inferiority of uncovered self-expandable metal stent to plastic stent for PBD by endoscopic retrograde cholangiopancreatography in patients with periampullary cancer undergoing curative intent pancreaticoduodenectomy.
Read the detailed description
Jaundice is one of the most common symptoms in patients with periampullary cancers including pancreatic cancer, common bile duct (CBD) cancer, ampulla of Vater (AoV) cancer, and duodenal cancer. Traditionally, preoperative biliary drainage (PBD) was routinely performed in these cancers because it might favorably influence sepsis, endotoxemia, and intravascular coagulation. However, a recent randomized control study reported that routine PBD in patients undergoing surgery for cancer of the pancreatic head increases the rate of complications. Therefore, routine PBD was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery.
In these patients with necessity of PBD, a plastic stent (PS) has been used because it is good for temporary use with cheap prices. However, it is sometimes occluded before surgery or not enough for rapid decompressing jaundice mainly because of its short diameter. In this aspect, a self-expandable metal stent (SEMS) has strength compared to PS because it has a longer diameter which enables rapid decompression with a fewer events of occlusion. However, SEMS is much more expensive than PS and the exact length of stent is more critical.
Although there are still lack of evidence which compares the results between PS and SEMS, National Comprehensive Cancer Network (NCCN) guidelines recently recommended the use of a short SEMS for pancreatic adenocarcinoma patients with cholangitis or fever. However, we needed more concrete evidence about this principle.
- Conditions
- Jaundice, Periampullary Cancer
- Being tested
- Stent
- Keywords
- ERCP, stent, preoperative biliary drainage
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentDevice
Endoscopic biliary stent insertion
| Study group | Role | What they receive |
|---|---|---|
| Plastic stent | Active comparator | 10 Fr plastic stent (Percuflex Amsterdam® or C-flex pigtail® or Advanix® Biliary stent) Receives: Device: Stent |
| Uncovered metal stent | Experimental | Uncovered metal stent (WallFlex® Biliary RX stent) Receives: Device: Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintervention rate until operation
Between preoperative biliary drainage and surgery, reintervention (re-preoperative biliary drainage) would be checked and analyzed.
Measured: Between preoperative biliary drainage and surgery
Secondary outcomes (5)
Other complication rate associated with endoscopic stent insertion and stent indwell
Until surgery, preoperative biliary drainage associated with complication would be checked and analyzed.
Measured: Between preoperative biliary drainage and surgery
Rate of decrease of total bilirubin
Amount of decrease of total bilirubin between preoperative biliary drainage and surgery would be checked.
Measured: Between preoperative biliary drainage and surgery
Time to operation
Interval between preoperative biliary drainage and surgery would be checked.
Measured: Between preoperative biliary drainage and surgery
Time to hospital discharge after pancreaticoduodenectomy
Interval between surgery and discharge would be checked.
Measured: 6 month
Mortality until 3 months after pancreaticoduodenectomy
The mortality rate would be calculated
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for JaundiceStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Jaihwan Kim, MD, Principal investigator, Division of Gastroenterology, Department of Internal Medicine, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787512
- Sponsor's protocol ID
- SNUBH-IMGPB-2016-01
- Status last verified
- Oct 2018
- First submitted
- 26 May 2016
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230.
PubMed 20071702Adams MA, Anderson MA, Myles JD, Khalatbari S, Scheiman JM. Self-expanding metal stents (SEMS) provide superior outcomes compared to plastic stents for pancreatic cancer patients undergoing neoadjuvant therapy. J Gastrointest Oncol. 2012 Dec;3(4):309-13. doi: 10.3978/j.issn.2078-6891.2011.050.
PubMed 23205306Decker C, Christein JD, Phadnis MA, Wilcox CM, Varadarajulu S. Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer. Surg Endosc. 2011 Jul;25(7):2364-7. doi: 10.1007/s00464-010-1552-6. Epub 2011 Mar 4.
PubMed 21373939
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Preoperative Biliary Drainage With Metal Versus Plastic Stents in Patients With Periampullary Cancer
- ClinicalTrials.gov ID
- NCT02787512
- Acronym / sponsor ID
- SNUBH-IMGPB-2016-01
- Conditions
- Jaundice, Periampullary Cancer
- Keywords
- ERCP, stent, preoperative biliary drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Jun 2016 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 1 Jun 2016 (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.
Currently, routine preoperative biliary drainage (PBD) was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery.
The aim of this clinical trial is to demonstrate non-inferiority of uncovered self-expandable metal stent to plastic stent for PBD by endoscopic retrograde cholangiopancreatography in patients with periampullary cancer undergoing curative intent pancreaticoduodenectomy.
Detailed description
Jaundice is one of the most common symptoms in patients with periampullary cancers including pancreatic cancer, common bile duct (CBD) cancer, ampulla of Vater (AoV) cancer, and duodenal cancer. Traditionally, preoperative biliary drainage (PBD) was routinely performed in these cancers because it might favorably influence sepsis, endotoxemia, and intravascular coagulation. However, a recent randomized control study reported that routine PBD in patients undergoing surgery for cancer of the pancreatic head increases the rate of complications. Therefore, routine PBD was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery.
In these patients with necessity of PBD, a plastic stent (PS) has been used because it is good for temporary use with cheap prices. However, it is sometimes occluded before surgery or not enough for rapid decompressing jaundice mainly because of its short diameter. In this aspect, a self-expandable metal stent (SEMS) has strength compared to PS because it has a longer diameter which enables rapid decompression with a fewer events of occlusion. However, SEMS is much more expensive than PS and the exact length of stent is more critical.
Although there are still lack of evidence which compares the results between PS and SEMS, National Comprehensive Cancer Network (NCCN) guidelines recently recommended the use of a short SEMS for pancreatic adenocarcinoma patients with cholangitis or fever. However, we needed more concrete evidence about this principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plastic stent | Active comparator | Device: Stent10 Fr plastic stent (Percuflex Amsterdam® or C-flex pigtail® or Advanix® Biliary stent) |
| Uncovered metal stent | Experimental | Device: StentUncovered metal stent (WallFlex® Biliary RX stent) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 20-80 years old B. Patients with surgically resectable periampullary cancer on CT scans with or without MRI or PET-CT scans C. ECOG Performance score 0 or 1 D. Patients who need preoperative biliary drainage (PBD) because of one or more of following causes
- Cholangitis defined as revised Tokyo guidelines
- Level of total bilirubin >= 10mg/dL
- Expected time to operation >= 7 days
Key exclusion criteria (5 listed)
- Patients who received previous endoscopic biliary drainage or percutaneous biliary drainage B. Patients with acute pancreatitis before PBD
- Patients with bleeding tendency or coagulopathy or anticoagulation therapy as follows:
- Patients who take clopidogrel within 5 days before PBD
- Patients who take warfarin within 2 days before PBD
- Patients who receive heparin within 1 days before PBD D. Patients with pregnancy or suspected pregnancy E. Patients who are currently enrolled in another investigational trials that would directly interfere with current study
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 |
|---|---|---|
| StentEndoscopic biliary stent insertion | Device | Plastic stent, Uncovered metal stent |
Primary outcome
Reintervention rate until operation
Time frame: Between preoperative biliary drainage and surgery
Between preoperative biliary drainage and surgery, reintervention (re-preoperative biliary drainage) would be checked and analyzed.
5 secondary outcomes
Other complication rate associated with endoscopic stent insertion and stent indwell
Time frame: Between preoperative biliary drainage and surgery
Rate of decrease of total bilirubin
Time frame: Between preoperative biliary drainage and surgery
Time to operation
Time frame: Between preoperative biliary drainage and surgery
Time to hospital discharge after pancreaticoduodenectomy
Time frame: 6 month
Mortality until 3 months after pancreaticoduodenectomy
Time frame: 3 month
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 12 Feb 2019.
- Background: PubMed 20071702van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230.
- Background: PubMed 23205306Adams MA, Anderson MA, Myles JD, Khalatbari S, Scheiman JM. Self-expanding metal stents (SEMS) provide superior outcomes compared to plastic stents for pancreatic cancer patients undergoing neoadjuvant therapy. J Gastrointest Oncol. 2012 Dec;3(4):309-13. doi: 10.3978/j.issn.2078-6891.2011.050.
- Background: PubMed 21373939Decker C, Christein JD, Phadnis MA, Wilcox CM, Varadarajulu S. Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer. Surg Endosc. 2011 Jul;25(7):2364-7. doi: 10.1007/s00464-010-1552-6. Epub 2011 Mar 4.
- Individual participant dataSharing planned: No
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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.
Jaihwan Kim, MD principal investigator
Division of Gastroenterology, Department of Internal Medicine, Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent in people with Jaundice and Periampullary Cancer, run by Seoul National University Hospital at 2 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 4 inclusion and 5 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Reintervention rate until operation (time frame: Between preoperative biliary drainage and surgery). 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 NCT02787512, which also lists 3 linked publications.
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 12 Feb 2019.