NCT02376907

Brief 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
9 countries

25 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 3, 2015

Status Verified

February 1, 2015

Enrollment Period

4.4 years

First QC Date

February 19, 2015

Last Update Submit

February 25, 2015

Conditions

Jaundice

Keywords

distal malignant biliary obstructionendoscopic retrograde cholangiopancreatographyendoscopic ultrasoundgastric outlet obstructionstent

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 1 year

Secondary Outcomes (4)

  • Causes of recurrent biliary obstruction

    Up to 1 year

  • Functional success rate of biliary drainage

    2 weeks

  • Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity)

    30 days

  • Survival time

    Up to 2 year

Study Arms (1)

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.

Procedure: Biliary drainage

Interventions

Biliary drainagePROCEDURE

EUS-BD or ERCP

EUS-BD or ERCP with duodenal SEMS

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent the initial duodenal SEMS between Jan/1/2010 and Jun/30/2014 are included.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Eastern Hepatobiliary Hospital, Second Military Medical University

Shanghai, 200438, China

Location

The Prince of Wales Hospital

Shatin, Hong Kong

Location

Asian Institute of Gastroenterology

Hyderabad, 500082, India

Location

Fukushima Medical University

Fukushima, 960-1295, Japan

Location

Gifu University

Gifu, 501-1194, Japan

Location

Onomichi General Hospital

Hiroshima, 722-8508, Japan

Location

Teine-Keijinkai Hospital

Hokkaido, 006-8555, Japan

Location

Sapporo Medical University

Hokkaido, 060-8543, Japan

Location

Hokkaido University School of Medicine

Hokkaido, 060-8648, Japan

Location

Kinki University

Osaka, 589-8511, Japan

Location

Saitama Medical University International Medical Center

Saitama, 350-1298, Japan

Location

Graduate School of Medicine, The University of Tokyo

Tokyo, 113-8655, Japan

Location

Japanese Red Cross Medical Center

Tokyo, 150-8935, Japan

Location

Toho University Ohashi Medical Center

Tokyo, 153-8515, Japan

Location

Kanto Central Hospital

Tokyo, 158-0098, Japan

Location

Tokyo Medical University

Tokyo, 160-0023, Japan

Location

Tokyo Metropolitan Police Hospital

Tokyo, 164-8541, Japan

Location

Prince Court Medical Center

Kuala Lumpur, 50450, Malaysia

Location

Singapore General Hospital

Outram Road, 169608, Singapore

Location

Changi General Hospital

Simei New Town, 529889, Singapore

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Soon Chun Hyang University School of Medicine

Seoul, 140-887, South Korea

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Chulalongkorn University

Bangkok, 10330, Thailand

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (10)

  • 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.

    PMID: 16635221BACKGROUND

  • Kaw 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.

    PMID: 12404053BACKGROUND

  • Mutignani 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.

    PMID: 17516351BACKGROUND

  • Moon 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.

    PMID: 21655973BACKGROUND

  • Hamada 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.

    PMID: 23073685BACKGROUND

  • Kahaleh 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.

    PMID: 16813803BACKGROUND

  • Horaguchi 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.

    PMID: 19961522BACKGROUND

  • Itoi 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.

    PMID: 21688214BACKGROUND

  • Kawakubo 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.

    PMID: 22844572BACKGROUND

  • Hamada 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.

    PMID: 28982258DERIVED

Related Links

MeSH Terms

Conditions

JaundiceGastric Outlet Obstruction

Condition Hierarchy (Ancestors)

HyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsStomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Hiroyuki Isayama, MD, PhD

    Graduate School of Medicine, The University of Tokyo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 3, 2015

Study Start

January 1, 2010

Primary Completion

June 1, 2014

Study Completion

September 1, 2017

Last Updated

March 3, 2015

Record last verified: 2015-02

Locations

TW(1)MY(1)TH(2)CN(1)HK(1)IN(1)SG(2)KR(2)JP(14)