CholangiocarcinomaINTERCPTNCT03172832
A Trial of Percutaneous vs. Endoscopic Drainage of Suspected Klatskin Tumors
A study testing PTBD and ERC in people with Cholangiocarcinoma and Hilar Lymphadenopathy, run by Medical University of South Carolina at 25 sites in United States.
Trial summary
The optimal approach to the drainage of malignant obstruction at the biliary hilum remains uncertain. This is a randomized comparative effectiveness study of percutaneous transhepatic biliary drainage (PTBD) vs. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cholangiocarcinoma, Hilar Lymphadenopathy, Biliary Stricture
- What is being tested?
- PTBD and ERC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 25 sitesUnited States
- Study dates
- 20 Aug 2017to 12 Apr 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥40 (to reduce the likelihood of enrolling patients with obstruction due to primary sclerosing cholangitis)
- Cholestatic liver function tests, including serum alkaline phosphatase level ≥ 300 IU/L and bilirubin level ≥ 3.7 mg/dL
- Radiographic evidence of a biliary hilar stricture OR intrahepatic but no extrahepatic biliary ductal dilation
Who cannot join
- Known radiographic evidence of a Bismuth-Corlette type 1 biliary stricture
- Known diagnosis of primary sclerosing cholangitis without suspicion of dominant hilar stricture
- Recent gallbladder/biliary surgery within 12 months
- Known Mirizzi syndrome
- Known IgG4-mediated cholangiopathy
- Significant liver metastatic disease interfering with safe/effective PTBD
Show all 12Show fewer
- Significant ascites interfering with safe/effective PTBD
- Known regional malignant-appearing adenopathy or extra-biliary mass, indicating the need for concurrent EUS-FNA
- Prior ERCP or PTBD for hilar obstruction
- Surgically altered luminal anatomy other than prior Billroth reconstruction or Whipple resection
- Standard general contraindications to ERCP or PTBD (e.g. hemodynamic instability, uncorrected coagulopathy, etc.)
- Inability or unwillingness to follow study protocol
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21287
Boston University
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Case Western Reserve University
Cleveland, Ohio, 44106
Ohio State University
Columbus, Ohio, 43210
Methodist Hospital Dallas
Dallas, Texas, 75203
University of Florida
Gainesville, Florida, 32608
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Borland-Groover Clinic
Jacksonville, Florida, 32258
Dartmouth University
Lebanon, New Hampshire, 02714
University of Southern California
Los Angeles, California, 90033
Cedars Sinai Medical Center
Los Angeles, California, 90048
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University
Nashville, Tennessee, 49795
Yale University
New Haven, Connecticut, 74085
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Virginia Commonwealth University
Richmond, Virginia, 23219
Saint Louis University
St Louis, Missouri, 63103
Washington University
St Louis, Missouri, 63130
Stony Brook University
Stony Brook, New York, 11790
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: A Multicenter Randomized Trial of Percutaneous Transhepatic Biliary Drainage vs. Endoscopic Retrograde Cholangiography for Decompression of Suspected Malignant Biliary Hilar Obstruction - the INTERCPT Trial
The optimal approach to the drainage of malignant obstruction at the biliary hilum remains uncertain. This is a randomized comparative effectiveness study of percutaneous transhepatic biliary drainage (PTBD) vs. endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction.
Read the detailed description
Both percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiography (ERC) are accepted approaches in the management of patients with malignant obstruction at the biliary hilum. In routine clinical practice, ERC is generally favored on the basis of: 1) high technical and clinical success rates for other (non-hilar) indications; 2) the perceived safety of ERC relative to PTBD; 3) the perceived ability to perform more comprehensive tissue sampling at the time of ERC compared to PTBD; 4) the avoidance of external tubes which are often needed for PTBD; and 5) because patients with suspected malignant hilar obstruction (MHO) typically present to and are managed by gastroenterologists. However: 1) observational data suggest that PTBD is superior for achieving complete drainage of MHO1 and some guidelines recommend the percutaneous approach over ERC for Bismuth type 3 \& 4 hilar strictures; 2) the generally quoted risks of PTBD are based on outdated studies and may be exaggerated; and 3) endoscopic diagnosis of indeterminate biliary strictures remains suboptimal despite the use of cholangioscopy and multi-modal sampling.
Although many patients who undergo initial ERC require subsequent PTBD for adequate drainage, no randomized trials comparing the two modalities for suspected MHO have been published. The main hypothesis is that even though PTBD will be more effective than ERC for decompression of suspected MHO, this advantage will be offset by the favorable safety profile and superior diagnostic capability of ERC. If, however, PTBD is found to be substantially superior (by a pre-specified margin) in terms of drainage, or if the potential advantages of ERC are not realized, then the existing clinical approach to MHO must be reappraised. Moreover, identifying patient and stricture characteristics that predict response to PTBD or ERC may be important for informing clinical decision-making and guidelines.
- Conditions
- Cholangiocarcinoma, Hilar Lymphadenopathy, Biliary Stricture
- Being tested
- PTBD, ERC
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTBDProcedure or surgery
Percutaneous access and tube placement into the bile duct
ERCProcedure or surgery
Endoscopic access and stent placement in the bile duct
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Transhepatic Drainage | Active comparator | Subjects randomized to this arm will undergo PTBD as the first drainage intervention. Receives: Procedure: PTBD |
| Endoscopic Retrograde Cholangiography | Active comparator | Subjects randomized to this arm will undergo ERC as the first drainage intervention. Receives: Procedure: ERC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful biliary drainage
50% reduction in bilirubin level within 2 weeks of the study intervention without additional ERC or PTBD
Measured: 2 weeks
Secondary outcomes (5)
Alternate definition of successful biliary drainage
improvement in the serum bilirubin level to ≤2.5 mg/dL as a result of the index (randomization) intervention without the need for additional procedures.
Measured: 6 months
Adverse events
Adverse events related to PTBD and ERC, defined according to standard consensus guideline documents published in the interventional radiology and gastroenterology literature respectively.
Measured: 6 months
Adequate tissue diagnosis
A definitive diagnosis of malignancy documented in the subject's medical record.
Measured: 6 months
Quality of life measure
Promis Global Health Scale
Measured: 2-3 months after initial procedure
Quality of life measure
SF12 health survey
Measured: 2-3 months after initial procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start20 Aug 2017
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Why it stopped: Slow accrual; recommended by DSMB.
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 CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Parallel groups
- Model description
- Randomized comparative effectiveness trial
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Virginia Commonwealth University, Vanderbilt University, Stony Brook University, University of Southern California, Case Western Reserve University, Medical College of Wisconsin, Dartmouth University, University of Florida, Northwestern University, Johns Hopkins University, Washington University School of Medicine, University of Michigan, Boston University, Ohio State University, Borland-Groover Clinic, Methodist Health System, St. Louis University, Fox Chase Cancer Center, Emory University, Cedars-Sinai Medical Center, Johns Hopkins Community Physicians, University of Virginia
- Responsible party
- Principal investigator, Badih Elmunzer, Medical University of South Carolina
- Investigators
- B. Joseph Elmunzer, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172832
- Sponsor's protocol ID
- Pro00063825
- Acronym
- INTERCPT
- Status last verified
- Mar 2020
- First submitted
- 26 May 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Kawas F, Aslanian H, Baillie J, Banovac F, Buscaglia JM, Buxbaum J, Chak A, Chong B, Cote GA, Draganov PV, Dua K, Durkalski V, Elmunzer BJ, Foster LD, Gardner TB, Geller BS, Jamidar P, Jamil LH, Keswani RN, Khashab MA, Lang GD, Law R, Lichtenstein D, Lo SK, McCarthy S, Melo S, Mullady D, Nieto J, Bayne Selby J, Singh VK, Spitzer RL, Strife B, Tarnaksy P, Taylor JR, Tokar J, Wang AY, Williams A, Willingham F, Yachimski P; In alphabetical order for the INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial. Trials. 2018 Feb 14;19(1):108. doi: 10.1186/s13063-018-2473-2.
PubMed 29444707
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Trial of Percutaneous Transhepatic Biliary Drainage vs. Endoscopic Retrograde Cholangiography for Decompression of Suspected Malignant Biliary Hilar Obstruction - the INTERCPT Trial
- ClinicalTrials.gov ID
- NCT03172832
- Acronym / sponsor ID
- INTERCPT / Pro00063825
- Conditions
- Cholangiocarcinoma, Hilar Lymphadenopathy, Biliary Stricture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual; recommended by DSMB.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Yale University, Virginia Commonwealth University, Vanderbilt University, Stony Brook University, University of Southern California, Case Western Reserve University, Medical College of Wisconsin, Dartmouth University, University of Florida, Northwestern University, Johns Hopkins University, Washington University School of Medicine, University of Michigan, Boston University, Ohio State University, Borland-Groover Clinic, Methodist Health System, St. Louis University, Fox Chase Cancer Center, Emory University, Cedars-Sinai Medical Center, Johns Hopkins Community Physicians, University of Virginia
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 1 Jun 2017 (actual)
- 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 optimal approach to the drainage of malignant obstruction at the biliary hilum remains uncertain. This is a randomized comparative effectiveness study of percutaneous transhepatic biliary drainage (PTBD) vs. endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction.
Detailed description
Both percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiography (ERC) are accepted approaches in the management of patients with malignant obstruction at the biliary hilum. In routine clinical practice, ERC is generally favored on the basis of: 1) high technical and clinical success rates for other (non-hilar) indications; 2) the perceived safety of ERC relative to PTBD; 3) the perceived ability to perform more comprehensive tissue sampling at the time of ERC compared to PTBD; 4) the avoidance of external tubes which are often needed for PTBD; and 5) because patients with suspected malignant hilar obstruction (MHO) typically present to and are managed by gastroenterologists. However: 1) observational data suggest that PTBD is superior for achieving complete drainage of MHO1 and some guidelines recommend the percutaneous approach over ERC for Bismuth type 3 \& 4 hilar strictures; 2) the generally quoted risks of PTBD are based on outdated studies and may be exaggerated; and 3) endoscopic diagnosis of indeterminate biliary strictures remains suboptimal despite the use of cholangioscopy and multi-modal sampling.
Although many patients who undergo initial ERC require subsequent PTBD for adequate drainage, no randomized trials comparing the two modalities for suspected MHO have been published. The main hypothesis is that even though PTBD will be more effective than ERC for decompression of suspected MHO, this advantage will be offset by the favorable safety profile and superior diagnostic capability of ERC. If, however, PTBD is found to be substantially superior (by a pre-specified margin) in terms of drainage, or if the potential advantages of ERC are not realized, then the existing clinical approach to MHO must be reappraised. Moreover, identifying patient and stricture characteristics that predict response to PTBD or ERC may be important for informing clinical decision-making and guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized comparative effectiveness trial
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Transhepatic Drainage | Active comparator | Procedure: PTBDSubjects randomized to this arm will undergo PTBD as the first drainage intervention. |
| Endoscopic Retrograde Cholangiography | Active comparator | Procedure: ERCSubjects randomized to this arm will undergo ERC as the first drainage intervention. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥40 (to reduce the likelihood of enrolling patients with obstruction due to primary sclerosing cholangitis)
- Cholestatic liver function tests, including serum alkaline phosphatase level ≥ 300 IU/L and bilirubin level ≥ 3.7 mg/dL
- Radiographic evidence of a biliary hilar stricture OR intrahepatic but no extrahepatic biliary ductal dilation
Key exclusion criteria (12 listed)
- Known radiographic evidence of a Bismuth-Corlette type 1 biliary stricture
- Known diagnosis of primary sclerosing cholangitis without suspicion of dominant hilar stricture
- Recent gallbladder/biliary surgery within 12 months
- Known Mirizzi syndrome
- Known IgG4-mediated cholangiopathy
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 |
|---|---|---|
| PTBDPercutaneous access and tube placement into the bile duct | Procedure or surgery | Percutaneous Transhepatic Drainage |
| ERCEndoscopic access and stent placement in the bile duct | Procedure or surgery | Endoscopic Retrograde Cholangiography |
Primary outcome
Successful biliary drainage
Time frame: 2 weeks
50% reduction in bilirubin level within 2 weeks of the study intervention without additional ERC or PTBD
5 secondary outcomes
Alternate definition of successful biliary drainage
Time frame: 6 months
Adverse events
Time frame: 6 months
Adequate tissue diagnosis
Time frame: 6 months
Quality of life measure
Time frame: 2-3 months after initial procedure
Quality of life measure
Time frame: 2-3 months after initial procedure
Results and safety
The study was stopped early (reason given: Slow accrual; recommended by DSMB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 29444707Al-Kawas F, Aslanian H, Baillie J, Banovac F, Buscaglia JM, Buxbaum J, Chak A, Chong B, Cote GA, Draganov PV, Dua K, Durkalski V, Elmunzer BJ, Foster LD, Gardner TB, Geller BS, Jamidar P, Jamil LH, Keswani RN, Khashab MA, Lang GD, Law R, Lichtenstein D, Lo SK, McCarthy S, Melo S, Mullady D, Nieto J, Bayne Selby J, Singh VK, Spitzer RL, Strife B, Tarnaksy P, Taylor JR, Tokar J, Wang AY, Williams A, Willingham F, Yachimski P; In alphabetical order for the INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial. Trials. 2018 Feb 14;19(1):108. doi: 10.1186/s13063-018-2473-2.
- 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.
B. Joseph Elmunzer principal investigator
Medical University of South Carolina
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTBD and ERC in people with Cholangiocarcinoma and Hilar Lymphadenopathy, run by Medical University of South Carolina at 25 sites in United States.
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 12 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: stopped early, as of the sponsor's last update on 25 Mar 2020. 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 United States. 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 was stopped early (reason given: Slow accrual; recommended by DSMB.). 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?
Successful biliary drainage (time frame: 2 weeks). 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 NCT03172832, 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 25 Mar 2020.