Periampullary Cancers With Obstructive JaundiceNCT01134276
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
A study testing biliary drainage in people with Periampullary Cancers With Obstructive Jaundice and Pancreas Head Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer, Bile Duct Cancer
- What is being tested?
- biliary drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient who have periampullary tumors causing obstructive jaundice
- patient age: ≥20 and ≤85
- resectable state of disease
- no history of previous chemotherapy or radiotherapy
- patients without uncontrollable severe cardiovascular, respiratory disease
- Karnofsky performance scale ≥70
- informed consent
Who cannot join
- patients with distant metastasis or locally advanced disease with major vascular invasion
- duodenal cancer
- biliary drainage before randomization
- previous chemotherapy or radiotherapy
- uncontrollable active infection except cholangitis
- severe comorbid disease (cardiac, pulmonary, cerebrovascular)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, Seoul National University Hospital
Seoul
About this study
Official title: Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice
Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.
- Conditions
- Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
- Being tested
- biliary drainage
- Medical subject headings
- Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biliary drainageProcedure or surgery
biliary drainage via PTBD or ERBD/ENBD
| Study group | Role | What they receive |
|---|---|---|
| PTBD | Active comparator | biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer Receives: Procedure: biliary drainage |
| ERBD | Active comparator | biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer Receives: Procedure: biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Infectious Complications After Biliary Drainage
at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
Measured: within 120 days after drainage
Secondary outcomes (2)
Change in Total Serum Bilirubin After Drainage
Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)
Measured: within 14 days after drainage
Total Hospital Cost During Admission After Biliary Drainage
Total hospital cost during admission after Biliary Drainage in US dollars
Measured: during hospital stay for biliary drainage procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periampullary Cancers With Obstructive 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun-Whe Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134276
- Sponsor's protocol ID
- H-1001-047-307
- Status last verified
- Jun 2014
- First submitted
- 4 May 2010
- Last updated
- 11 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
van der Gaag NA, de Castro SM, Rauws EA, Bruno MJ, van Eijck CH, Kuipers EJ, Gerritsen JJ, Rutten JP, Greve JW, Hesselink EJ, Klinkenbijl JH, Rinkes IH, Boerma D, Bonsing BA, van Laarhoven CJ, Kubben FJ, van der Harst E, Sosef MN, Bosscha K, de Hingh IH, Th de Wit L, van Delden OM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial). BMC Surg. 2007 Mar 12;7:3. doi: 10.1186/1471-2482-7-3.
PubMed 17352805Speer AG, Cotton PB, Russell RC, Mason RR, Hatfield AR, Leung JW, MacRae KD, Houghton J, Lennon CA. Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice. Lancet. 1987 Jul 11;2(8550):57-62. doi: 10.1016/s0140-6736(87)92733-4.
PubMed 2439854Sewnath ME, Karsten TM, Prins MH, Rauws EJ, Obertop H, Gouma DJ. A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice. Ann Surg. 2002 Jul;236(1):17-27. doi: 10.1097/00000658-200207000-00005.
PubMed 12131081Saiki S, Chijiiwa K, Komura M, Yamaguchi K, Kuroki S, Tanaka M. Preoperative internal biliary drainage is superior to external biliary drainage in liver regeneration and function after hepatectomy in obstructive jaundiced rats. Ann Surg. 1999 Nov;230(5):655-62. doi: 10.1097/00000658-199911000-00007.
PubMed 10561089
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice
- ClinicalTrials.gov ID
- NCT01134276
- Acronym / sponsor ID
- H-1001-047-307
- Conditions
- Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Posted 11 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTBD | Active comparator | Procedure: biliary drainagebiliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer |
| ERBD | Active comparator | Procedure: biliary drainagebiliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patient who have periampullary tumors causing obstructive jaundice
- patient age: ≥20 and ≤85
- resectable state of disease
- no history of previous chemotherapy or radiotherapy
- patients without uncontrollable severe cardiovascular, respiratory disease
Key exclusion criteria (6 listed)
- patients with distant metastasis or locally advanced disease with major vascular invasion
- duodenal cancer
- biliary drainage before randomization
- previous chemotherapy or radiotherapy
- uncontrollable active infection except cholangitis
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 drainagebiliary drainage via PTBD or ERBD/ENBD | Procedure or surgery | ERBD, PTBD |
Primary outcome
Incidence of Infectious Complications After Biliary Drainage
Time frame: within 120 days after drainage
at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
2 secondary outcomes
Change in Total Serum Bilirubin After Drainage
Time frame: within 14 days after drainage
Total Hospital Cost During Admission After Biliary Drainage
Time frame: during hospital stay for biliary drainage procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17352805van der Gaag NA, de Castro SM, Rauws EA, Bruno MJ, van Eijck CH, Kuipers EJ, Gerritsen JJ, Rutten JP, Greve JW, Hesselink EJ, Klinkenbijl JH, Rinkes IH, Boerma D, Bonsing BA, van Laarhoven CJ, Kubben FJ, van der Harst E, Sosef MN, Bosscha K, de Hingh IH, Th de Wit L, van Delden OM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial). BMC Surg. 2007 Mar 12;7:3. doi: 10.1186/1471-2482-7-3.
- Background: PubMed 2439854Speer AG, Cotton PB, Russell RC, Mason RR, Hatfield AR, Leung JW, MacRae KD, Houghton J, Lennon CA. Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice. Lancet. 1987 Jul 11;2(8550):57-62. doi: 10.1016/s0140-6736(87)92733-4.
- Background: PubMed 12131081Sewnath ME, Karsten TM, Prins MH, Rauws EJ, Obertop H, Gouma DJ. A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice. Ann Surg. 2002 Jul;236(1):17-27. doi: 10.1097/00000658-200207000-00005.
- Background: PubMed 10561089Saiki S, Chijiiwa K, Komura M, Yamaguchi K, Kuroki S, Tanaka M. Preoperative internal biliary drainage is superior to external biliary drainage in liver regeneration and function after hepatectomy in obstructive jaundiced rats. Ann Surg. 1999 Nov;230(5):655-62. doi: 10.1097/00000658-199911000-00007.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biliary drainage in people with Periampullary Cancers With Obstructive Jaundice and Pancreas Head Cancer, run by Seoul National University Hospital at 1 site 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 7 inclusion and 6 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 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 11 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Infectious Complications After Biliary Drainage (time frame: within 120 days after drainage). 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 NCT01134276, which also lists 4 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 11 Jun 2014.