JaundiceNCT02376907
Biliary Drainage in Patients With Duodenal Metal Stent
An observational study of Jaundice, run by Tokyo University at 25 sites in 9 countries.
Trial summary
This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Jaundice
- What is being tested?
- Biliary drainage
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 25 sitesin 9 countries
- Study dates
- Jan 2010to Sep 2017
- Phase
- Observational
- 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
Study population: Patients who underwent the initial duodenal SEMS between Jan/1/2010 and Jun/30/2014 are included.
Who may be able to join
- Patients who underwent endoscopic placement of a duodenal SEMS for nonresectable malignant GOO.
- Patients who underwent endoscopic biliary drainage for nonresectable MBO.
- MBO was located ≥ 2 cm from the bifurcation.
- Patients who could be followed up more than three months after completion of both biliary drainage and duodenal SEMS placement.
- Age ≥20 years.
- Irrespective of sex and a primary disease.
Who cannot join
- Patients who underwent surgical bypass for GOO.
- Patients who underwent percutaneous and surgical biliary drainage prior to the placement of duodenal SEMS.
- Patients with altered gastrointestinal anatomy (Billroth-II reconstruction, Roux-en-Y reconstruction, etc.).
- Patients who would not give a consent to the report of their own data.
- Patients considered ineligible for inclusion in the study by an investigator for other reasons.
Trial locations and contacts
25 sites in 9 countries.
25 sites in 9 countries
Japan14 sites
Fukushima Medical University
Fukushima, 960-1295
Gifu University
Gifu, 501-1194
Onomichi General Hospital
Hiroshima, 722-8508
Teine-Keijinkai Hospital
Hokkaido, 006-8555
Sapporo Medical University
Hokkaido, 060-8543
Hokkaido University School of Medicine
Hokkaido, 060-8648
Kinki University
Osaka, 589-8511
Saitama Medical University International Medical Center
Saitama, 350-1298
Graduate School of Medicine, The University of Tokyo
Tokyo, 113-8655
Japanese Red Cross Medical Center
Tokyo, 150-8935
Toho University Ohashi Medical Center
Tokyo, 153-8515
Kanto Central Hospital
Tokyo, 158-0098
Tokyo Medical University
Tokyo, 160-0023
Tokyo Metropolitan Police Hospital
Tokyo, 164-8541
Singapore2 sites
Singapore General Hospital
Outram Road, 169608
Changi General Hospital
Simei New Town, 529889
South Korea2 sites
Asan Medical Center
Seoul, 138-736
Soon Chun Hyang University School of Medicine
Seoul, 140-887
Thailand2 sites
Chulalongkorn University
Bangkok, 10330
Rajavithi Hospital
Bangkok, 10400
China1 site
Eastern Hepatobiliary Hospital, Second Military Medical University
Shanghai, 200438
About this study
Official title: Multinational Study on Endoscopic Management of Distal Malignant Biliary Obstruction Combined With Gastric Outlet Obstruction
This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO.
Read the detailed description
This is a multinational multicenter retrospective cohort study to evaluate the outcomes of endoscopic biliary drainage in patients with a duodenal SEMS. Endoscopic ultrasound-guided biliary drainage (EUS-BD), including choledochoduodenostomy, hepaticogastrostomy, antegrade biliary stenting or a combination, and endoscopic retrograde cholangiopancreatography (ERCP) with stenting are to be compared. Specifically, the outcomes are to be evaluated according to the timing of distal MBO in relation to GOO and the location of GOO.
- Conditions
- Jaundice
- Being tested
- Biliary drainage
- Keywords
- distal malignant biliary obstruction, endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, gastric outlet obstruction, stent
- Medical subject headings
- Jaundice, Gastric Outlet Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary drainageProcedure or surgery
EUS-BD or ERCP
| Study group | Role | What they receive |
|---|---|---|
| EUS-BD or ERCP with duodenal SEMS | Patients who underwent endoscopic placement of a duodenal self-expandable metal stent (SEMS) for nonresectable malignant GOO and endoscopic biliary drainage for nonresectable distal MBO. Receives: Procedure: Biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrent biliary obstruction
Recurrent biliary obstruction is defined as a composite endpoint of either occlusion or migration of biliary stent, and time to recurrent biliary obstruction is time from biliary drainage to recurrence of biliary obstruction.
Measured: Up to 1 year
Secondary outcomes (4)
Causes of recurrent biliary obstruction
Causes of recurrent biliary obstruction include sludge, food impaction, ingrowth, tumor overgrowth, hemobilia and others.
Measured: Up to 1 year
Functional success rate of biliary drainage
Functional success is defined when bilirubin decreases < 50% or is normalized within 2 weeks.
Measured: 2 weeks
Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity)
Complications and their severity are determined using the American Society of Gastrointestinal Endoscopy guidelines.
Measured: 30 days
Survival time
Survival time is defined as the period between biliary stent placement and death.
Measured: Up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJan 2010
- Primary completionJun 2014
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for JaundiceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroyuki Isayama, MD, PhD, Tokyo University
- Investigators
- Hiroyuki Isayama, MD, PhD, Principal investigator, Graduate School of Medicine, The University of Tokyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376907
- Sponsor's protocol ID
- 10639
- Status last verified
- Feb 2015
- First submitted
- 19 Feb 2015
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Maire F, Hammel P, Ponsot P, Aubert A, O'Toole D, Hentic O, Levy P, Ruszniewski P. Long-term outcome of biliary and duodenal stents in palliative treatment of patients with unresectable adenocarcinoma of the head of pancreas. Am J Gastroenterol. 2006 Apr;101(4):735-42. doi: 10.1111/j.1572-0241.2006.00559.x.
PubMed 16635221Kaw M, Singh S, Gagneja H. Clinical outcome of simultaneous self-expandable metal stents for palliation of malignant biliary and duodenal obstruction. Surg Endosc. 2003 Mar;17(3):457-61. doi: 10.1007/s00464-002-8541-3. Epub 2002 Oct 31.
PubMed 12404053Mutignani M, Tringali A, Shah SG, Perri V, Familiari P, Iacopini F, Spada C, Costamagna G. Combined endoscopic stent insertion in malignant biliary and duodenal obstruction. Endoscopy. 2007 May;39(5):440-7. doi: 10.1055/s-2007-966327.
PubMed 17516351Moon JH, Choi HJ. Endoscopic double-metallic stenting for malignant biliary and duodenal obstructions. J Hepatobiliary Pancreat Sci. 2011 Sep;18(5):658-63. doi: 10.1007/s00534-011-0409-2.
PubMed 21655973Hamada T, Nakai Y, Isayama H, Sasaki T, Kogure H, Kawakubo K, Sasahira N, Yamamoto N, Togawa O, Mizuno S, Ito Y, Hirano K, Toda N, Tada M, Koike K. Duodenal metal stent placement is a risk factor for biliary metal stent dysfunction: an analysis using a time-dependent covariate. Surg Endosc. 2013 Apr;27(4):1243-8. doi: 10.1007/s00464-012-2585-9. Epub 2012 Oct 17.
PubMed 23073685Kahaleh M, Hernandez AJ, Tokar J, Adams RB, Shami VM, Yeaton P. Interventional EUS-guided cholangiography: evaluation of a technique in evolution. Gastrointest Endosc. 2006 Jul;64(1):52-9. doi: 10.1016/j.gie.2006.01.063.
PubMed 16813803Horaguchi J, Fujita N, Noda Y, Kobayashi G, Ito K, Obana T, Takasawa O, Koshita S, Kanno Y. Endosonography-guided biliary drainage in cases with difficult transpapillary endoscopic biliary drainage. Dig Endosc. 2009 Oct;21(4):239-44. doi: 10.1111/j.1443-1661.2009.00899.x.
PubMed 19961522Itoi T, Isayama H, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Tsuji S, Ishii K, Ikeuchi N, Tanaka R, Umeda J, Moriyasu F, Kawakami H. Stent selection and tips on placement technique of EUS-guided biliary drainage: transduodenal and transgastric stenting. J Hepatobiliary Pancreat Sci. 2011 Sep;18(5):664-72. doi: 10.1007/s00534-011-0410-9.
PubMed 21688214Kawakubo K, Isayama H, Nakai Y, Sasahira N, Kogure H, Sasaki T, Hirano K, Tada M, Koike K. Simultaneous Duodenal Metal Stent Placement and EUS-Guided Choledochoduodenostomy for Unresectable Pancreatic Cancer. Gut Liver. 2012 Jul;6(3):399-402. doi: 10.5009/gnl.2012.6.3.399. Epub 2012 Jul 12.
PubMed 22844572Hamada T, Nakai Y, Lau JY, Moon JH, Hayashi T, Yasuda I, Hu B, Seo DW, Kawakami H, Kuwatani M, Katanuma A, Kitano M, Ryozawa S, Hanada K, Iwashita T, Ito Y, Yagioka H, Togawa O, Maetani I, Isayama H. International study of endoscopic management of distal malignant biliary obstruction combined with duodenal obstruction. Scand J Gastroenterol. 2018 Jan;53(1):46-55. doi: 10.1080/00365521.2017.1382567. Epub 2017 Oct 6.
PubMed 28982258
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multinational Study on Endoscopic Management of Distal Malignant Biliary Obstruction Combined With Gastric Outlet Obstruction
- ClinicalTrials.gov ID
- NCT02376907
- Acronym / sponsor ID
- 10639
- Conditions
- Jaundice
- Keywords
- distal malignant biliary obstruction, endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, gastric outlet obstruction, stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2017 (estimated)
- First posted
- 3 Mar 2015 (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 is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO.
Detailed description
This is a multinational multicenter retrospective cohort study to evaluate the outcomes of endoscopic biliary drainage in patients with a duodenal SEMS. Endoscopic ultrasound-guided biliary drainage (EUS-BD), including choledochoduodenostomy, hepaticogastrostomy, antegrade biliary stenting or a combination, and endoscopic retrograde cholangiopancreatography (ERCP) with stenting are to be compared. Specifically, the outcomes are to be evaluated according to the timing of distal MBO in relation to GOO and the location of GOO.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-BD or ERCP with duodenal SEMS | – | Procedure: Biliary drainagePatients who underwent endoscopic placement of a duodenal self-expandable metal stent (SEMS) for nonresectable malignant GOO and endoscopic biliary drainage for nonresectable distal MBO. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent the initial duodenal SEMS between Jan/1/2010 and Jun/30/2014 are included.
Key inclusion criteria (6 listed)
- Patients who underwent endoscopic placement of a duodenal SEMS for nonresectable malignant GOO.
- Patients who underwent endoscopic biliary drainage for nonresectable MBO.
- MBO was located ≥ 2 cm from the bifurcation.
- Patients who could be followed up more than three months after completion of both biliary drainage and duodenal SEMS placement.
- Age ≥20 years.
Key exclusion criteria (5 listed)
- Patients who underwent surgical bypass for GOO.
- Patients who underwent percutaneous and surgical biliary drainage prior to the placement of duodenal SEMS.
- Patients with altered gastrointestinal anatomy (Billroth-II reconstruction, Roux-en-Y reconstruction, etc.).
- Patients who would not give a consent to the report of their own data.
- Patients considered ineligible for inclusion in the study by an investigator for other reasons.
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 |
|---|---|---|
| Biliary drainageEUS-BD or ERCP | Procedure or surgery | EUS-BD or ERCP with duodenal SEMS |
Primary outcome
Time to recurrent biliary obstruction
Time frame: Up to 1 year
Recurrent biliary obstruction is defined as a composite endpoint of either occlusion or migration of biliary stent, and time to recurrent biliary obstruction is time from biliary drainage to recurrence of biliary obstruction.
4 secondary outcomes
Causes of recurrent biliary obstruction
Time frame: Up to 1 year
Functional success rate of biliary drainage
Time frame: 2 weeks
Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity)
Time frame: 30 days
Survival time
Time frame: Up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Background: PubMed 16635221Maire F, Hammel P, Ponsot P, Aubert A, O'Toole D, Hentic O, Levy P, Ruszniewski P. Long-term outcome of biliary and duodenal stents in palliative treatment of patients with unresectable adenocarcinoma of the head of pancreas. Am J Gastroenterol. 2006 Apr;101(4):735-42. doi: 10.1111/j.1572-0241.2006.00559.x.
- Background: PubMed 12404053Kaw M, Singh S, Gagneja H. Clinical outcome of simultaneous self-expandable metal stents for palliation of malignant biliary and duodenal obstruction. Surg Endosc. 2003 Mar;17(3):457-61. doi: 10.1007/s00464-002-8541-3. Epub 2002 Oct 31.
- Background: PubMed 17516351Mutignani M, Tringali A, Shah SG, Perri V, Familiari P, Iacopini F, Spada C, Costamagna G. Combined endoscopic stent insertion in malignant biliary and duodenal obstruction. Endoscopy. 2007 May;39(5):440-7. doi: 10.1055/s-2007-966327.
- Background: PubMed 21655973Moon JH, Choi HJ. Endoscopic double-metallic stenting for malignant biliary and duodenal obstructions. J Hepatobiliary Pancreat Sci. 2011 Sep;18(5):658-63. doi: 10.1007/s00534-011-0409-2.
- Background: PubMed 23073685Hamada T, Nakai Y, Isayama H, Sasaki T, Kogure H, Kawakubo K, Sasahira N, Yamamoto N, Togawa O, Mizuno S, Ito Y, Hirano K, Toda N, Tada M, Koike K. Duodenal metal stent placement is a risk factor for biliary metal stent dysfunction: an analysis using a time-dependent covariate. Surg Endosc. 2013 Apr;27(4):1243-8. doi: 10.1007/s00464-012-2585-9. Epub 2012 Oct 17.
- Background: PubMed 16813803Kahaleh M, Hernandez AJ, Tokar J, Adams RB, Shami VM, Yeaton P. Interventional EUS-guided cholangiography: evaluation of a technique in evolution. Gastrointest Endosc. 2006 Jul;64(1):52-9. doi: 10.1016/j.gie.2006.01.063.
- Background: PubMed 19961522Horaguchi J, Fujita N, Noda Y, Kobayashi G, Ito K, Obana T, Takasawa O, Koshita S, Kanno Y. Endosonography-guided biliary drainage in cases with difficult transpapillary endoscopic biliary drainage. Dig Endosc. 2009 Oct;21(4):239-44. doi: 10.1111/j.1443-1661.2009.00899.x.
- Background: PubMed 21688214Itoi T, Isayama H, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Tsuji S, Ishii K, Ikeuchi N, Tanaka R, Umeda J, Moriyasu F, Kawakami H. Stent selection and tips on placement technique of EUS-guided biliary drainage: transduodenal and transgastric stenting. J Hepatobiliary Pancreat Sci. 2011 Sep;18(5):664-72. doi: 10.1007/s00534-011-0410-9.
- Background: PubMed 22844572Kawakubo K, Isayama H, Nakai Y, Sasahira N, Kogure H, Sasaki T, Hirano K, Tada M, Koike K. Simultaneous Duodenal Metal Stent Placement and EUS-Guided Choledochoduodenostomy for Unresectable Pancreatic Cancer. Gut Liver. 2012 Jul;6(3):399-402. doi: 10.5009/gnl.2012.6.3.399. Epub 2012 Jul 12.
- Derived from this study: PubMed 28982258Hamada T, Nakai Y, Lau JY, Moon JH, Hayashi T, Yasuda I, Hu B, Seo DW, Kawakami H, Kuwatani M, Katanuma A, Kitano M, Ryozawa S, Hanada K, Iwashita T, Ito Y, Yagioka H, Togawa O, Maetani I, Isayama H. International study of endoscopic management of distal malignant biliary obstruction combined with duodenal obstruction. Scand J Gastroenterol. 2018 Jan;53(1):46-55. doi: 10.1080/00365521.2017.1382567. Epub 2017 Oct 6.
Related trials for Jaundice
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruitingObservational study
Real-world Evaluation of Different Endoscopic Biliary Drainage Techniques in Patients With Jaundice of Biliopancreatic Malignant Origin
Biliary Drainage, Endoscopic Ultrasound-Guided Drainage
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.
Hiroyuki Isayama, MD, PhD principal investigator
Graduate School of Medicine, The University of Tokyo
25 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaundice, run by Tokyo University at 25 sites in 9 countries.
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 6 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: status not confirmed, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan, Singapore, South Korea, Thailand, China and 4 more countries. 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?
Results are not available in the source record.
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?
Time to recurrent biliary obstruction (time frame: Up to 1 year). 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 NCT02376907, which also lists 10 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 3 Mar 2015.