Bile Duct Neoplasms MalignantNCT01459965
Stenting Malignant Jaundice for Quality of Life
A study testing ERCP with 10 French biliary plastic stent placement and ERCP with 11.5 French biliary plastic stent in people with Bile Duct Neoplasms Malignant, run by Indiana University.
Trial summary
Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bile Duct Neoplasms Malignant
- What is being tested?
- ERCP with 10 French biliary plastic stent placement and ERCP with 11.5 French biliary plastic stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Jul 1993to Nov 2004
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with suspected or proven malignant biliary obstruction who were unresectable or inoperable and were undergoing ERCP and biliary stenting for biliary depression.
Who cannot join
- Had previously undergone biliary stenting
- Surgery was planned
- A guidewire could not be passed through the stricture
- Suspected survival of < 3 months
- Impending duodenal obstruction
About this study
Official title: Endoscopic Palliation of Malignant Biliary Tract Obstruction: Emphasis on Improvement in Quality of Life
Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of the investigators study was to determine whether endoscopic stenting for MBDO results in improved QOL.
Read the detailed description
Most malignant tumors causing bile duct obstruction, such as pancreatic adenocarcinoma, gallbladder carcinoma or cholangiocarcinoma, have an extremely poor prognosis. At the time of diagnosis the majority of these tumors will be unresectable with a median survival of 4-6 months. Palliation is the goal for those patients with unresectable tumors and limited survival and for those at high risk for attempts at curative resection.
Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic stent insertion is considered the method of choice for palliative treatment of malignant bile duct obstruction (MBDO). However, it can cause complications, such as pancreatitis, bleeding, perforation, cholangitis and stent migration in a significant proportion of treated patients. Clogging of plastic stents is a predictable consequence and requires periodic stent exchanges with attendant risks and costs. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, the role of stenting in patients with jaundice alone, abdominal pain, or failure to thrive due to malignancy is less clear. Given the risk for complications and costs, endoscopic therapy might be justified in these clinical scenarios if quality of life (QOL) is significantly improved. A few available studies have demonstrated improved QOL in stented patients. However, these studies include a small number of patients and/or are retrospective in design. Therefore, more evidence to support routine palliative biliary drainage in patients with MBDO is desired.
- Conditions
- Bile Duct Neoplasms Malignant
- Being tested
- ERCP with 10 French biliary plastic stent placement, ERCP with 11.5 French biliary plastic stent
- Keywords
- Jaundice, Biliary stents, Palliation, Quality of Life, Endoscopic Retrograde Cholangiography
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with 10 French biliary plastic stent placementProcedure or surgery
Stent placement of a 10 French biliary plastic stent
ERCP with 11.5 French biliary plastic stentProcedure or surgery
biliary plastic stent placement
| Study group | Role | What they receive |
|---|---|---|
| 10 French Stent | Active comparator | 10 French biliary plastic stent Receives: Procedure: ERCP with 10 French biliary plastic stent placement |
| 11.5 French stent | Active comparator | 11.5 French biliary plastic stent Receives: Procedure: ERCP with 11.5 French biliary plastic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented change in Quality Of Life
Documented change in QOL over the first month and over six months after successful biliary drainage compared with that before the procedure. The FACT-G questionnaire administered at baseline, at 1 month after stent insertion and at 180 days after stent insertion was used to assess this outcome. Change from baseline was analyzed at each of these time points separately.
Measured: 180 days after stent insertion
Secondary outcomes (1)
Documented change in symptoms and concerns specific for patients with MBDO
An additional 10 item questionnaire was administered at baseline, at 1 month after biliary stenting and at 180 days after biliary stenting.
Measured: 180 days after stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startJul 1993
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Bile Duct Neoplasms MalignantStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy, American College of Gastroenterology
- Responsible party
- Sponsor
- Investigators
- Stuart Sherman, MD, Principal investigator, Indiana University Medical CenterGlen A Lehman, MD, Principal investigator, Indiana Univesity Medical CenterJames Frankes, MD, Principal investigator, Rockford GE AssociatesJohn Johanson, MD, Principal investigator, Rockford GE AssociatesTahir Qaseem, MD, Principal investigator, MaineHealthDouglas Howell, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459965
- Sponsor's protocol ID
- 9307-04
- Status last verified
- Oct 2011
- First submitted
- 21 Oct 2011
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Jemal A, Thomas A, Murray T, Thun M. Cancer statistics, 2002. CA Cancer J Clin. 2002 Jan-Feb;52(1):23-47. doi: 10.3322/canjclin.52.1.23.
PubMed 11814064Lowy AM. From bad to worse: prognostic factors in pancreatic cancer. Ann Surg Oncol. 2004 Feb;11(2):117-8. doi: 10.1245/aso.2004.12.930. No abstract available.
PubMed 14761910Lowenfels AB, Maisonneuve P, Boyle P (1998) Epidemiology of pancreatic cancer. In: Howard J, Idezuki Y, Ihse I, Prinz R, eds. Surgical Diseases of the Pancreas. 3rd ed. Baltimore: Williams & Wilkins, 433-439
Speer 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 2439854Andersen JR, Sorensen SM, Kruse A, Rokkjaer M, Matzen P. Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice. Gut. 1989 Aug;30(8):1132-5. doi: 10.1136/gut.30.8.1132.
PubMed 2475392Motte S, Deviere J, Dumonceau JM, Serruys E, Thys JP, Cremer M. Risk factors for septicemia following endoscopic biliary stenting. Gastroenterology. 1991 Nov;101(5):1374-81. doi: 10.1016/0016-5085(91)90091-x.
PubMed 1936809Tarnasky PR, Cunningham JT, Hawes RH, Hoffman BJ, Uflacker R, Vujic I, Cotton PB. Transpapillary stenting of proximal biliary strictures: does biliary sphincterotomy reduce the risk of postprocedure pancreatitis? Gastrointest Endosc. 1997 Jan;45(1):46-51. doi: 10.1016/s0016-5107(97)70301-8.
PubMed 9013169Margulies C, Siqueira ES, Silverman WB, Lin XS, Martin JA, Rabinovitz M, Slivka A. The effect of endoscopic sphincterotomy on acute and chronic complications of biliary endoprostheses. Gastrointest Endosc. 1999 Jun;49(6):716-9. doi: 10.1016/s0016-5107(99)70288-9.
PubMed 10343215Giorgio PD, Luca LD. Comparison of treatment outcomes between biliary plastic stent placements with and without endoscopic sphincterotomy for inoperable malignant common bile duct obstruction. World J Gastroenterol. 2004 Apr 15;10(8):1212-4. doi: 10.3748/wjg.v10.i8.1212.
PubMed 15069728Johanson JF, Schmalz MJ, Geenen JE. Incidence and risk factors for biliary and pancreatic stent migration. Gastrointest Endosc. 1992 May-Jun;38(3):341-6. doi: 10.1016/s0016-5107(92)70429-5.
PubMed 1607087Speer AG, Cotton PB, Rode J, Seddon AM, Neal CR, Holton J, Costerton JW. Biliary stent blockage with bacterial biofilm. A light and electron microscopy study. Ann Intern Med. 1988 Apr;108(4):546-53. doi: 10.7326/0003-4819-108-4-546.
PubMed 2450501Frakes JT, Johanson JF, Stake JJ. Optimal timing for stent replacement in malignant biliary tract obstruction. Gastrointest Endosc. 1993 Mar-Apr;39(2):164-7. doi: 10.1016/s0016-5107(93)70058-9.
PubMed 8388345Ballinger AB, McHugh M, Catnach SM, Alstead EM, Clark ML. Symptom relief and quality of life after stenting for malignant bile duct obstruction. Gut. 1994 Apr;35(4):467-70. doi: 10.1136/gut.35.4.467.
PubMed 7513672Pereira-Lima JC, Jakobs R, Maier M, Kohler B, Benz C, Martin WR, Riemann JF. Endoscopic stenting in obstructive jaundice due to liver metastases: does it have a benefit for the patient? Hepatogastroenterology. 1996 Jul-Aug;43(10):944-8.
PubMed 8884318Luman W, Cull A, Palmer KR. Quality of life in patients stented for malignant biliary obstructions. Eur J Gastroenterol Hepatol. 1997 May;9(5):481-4. doi: 10.1097/00042737-199705000-00013.
PubMed 9187881
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Palliation of Malignant Biliary Tract Obstruction: Emphasis on Improvement in Quality of Life
- ClinicalTrials.gov ID
- NCT01459965
- Acronym / sponsor ID
- 9307-04
- Conditions
- Bile Duct Neoplasms Malignant
- Keywords
- Jaundice, Biliary stents, Palliation, Quality of Life, Endoscopic Retrograde Cholangiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy, American College of Gastroenterology
- Study start
- Jul 1993
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 26 Oct 2011 (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.
Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of the investigators study was to determine whether endoscopic stenting for MBDO results in improved QOL.
Detailed description
Most malignant tumors causing bile duct obstruction, such as pancreatic adenocarcinoma, gallbladder carcinoma or cholangiocarcinoma, have an extremely poor prognosis. At the time of diagnosis the majority of these tumors will be unresectable with a median survival of 4-6 months. Palliation is the goal for those patients with unresectable tumors and limited survival and for those at high risk for attempts at curative resection.
Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic stent insertion is considered the method of choice for palliative treatment of malignant bile duct obstruction (MBDO). However, it can cause complications, such as pancreatitis, bleeding, perforation, cholangitis and stent migration in a significant proportion of treated patients. Clogging of plastic stents is a predictable consequence and requires periodic stent exchanges with attendant risks and costs. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, the role of stenting in patients with jaundice alone, abdominal pain, or failure to thrive due to malignancy is less clear. Given the risk for complications and costs, endoscopic therapy might be justified in these clinical scenarios if quality of life (QOL) is significantly improved. A few available studies have demonstrated improved QOL in stented patients. However, these studies include a small number of patients and/or are retrospective in design. Therefore, more evidence to support routine palliative biliary drainage in patients with MBDO is desired.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 French Stent | Active comparator | Procedure: ERCP with 10 French biliary plastic stent placement10 French biliary plastic stent |
| 11.5 French stent | Active comparator | Procedure: ERCP with 11.5 French biliary plastic stent11.5 French biliary plastic stent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with suspected or proven malignant biliary obstruction who were unresectable or inoperable and were undergoing ERCP and biliary stenting for biliary depression.
Key exclusion criteria (5 listed)
- Had previously undergone biliary stenting
- Surgery was planned
- A guidewire could not be passed through the stricture
- Suspected survival of < 3 months
- Impending duodenal obstruction
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 |
|---|---|---|
| ERCP with 10 French biliary plastic stent placementStent placement of a 10 French biliary plastic stent | Procedure or surgery | 10 French Stent |
| ERCP with 11.5 French biliary plastic stentbiliary plastic stent placement | Procedure or surgery | 11.5 French stent |
Primary outcome
Documented change in Quality Of Life
Time frame: 180 days after stent insertion
Documented change in QOL over the first month and over six months after successful biliary drainage compared with that before the procedure. The FACT-G questionnaire administered at baseline, at 1 month after stent insertion and at 180 days after stent insertion was used to assess this outcome. Change from baseline was analyzed at each of these time points separately.
1 secondary outcome
Documented change in symptoms and concerns specific for patients with MBDO
Time frame: 180 days after stent placement
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 26 Oct 2011.
- Background: PubMed 11814064Jemal A, Thomas A, Murray T, Thun M. Cancer statistics, 2002. CA Cancer J Clin. 2002 Jan-Feb;52(1):23-47. doi: 10.3322/canjclin.52.1.23.
- Background: PubMed 14761910Lowy AM. From bad to worse: prognostic factors in pancreatic cancer. Ann Surg Oncol. 2004 Feb;11(2):117-8. doi: 10.1245/aso.2004.12.930. No abstract available.
- BackgroundLowenfels AB, Maisonneuve P, Boyle P (1998) Epidemiology of pancreatic cancer. In: Howard J, Idezuki Y, Ihse I, Prinz R, eds. Surgical Diseases of the Pancreas. 3rd ed. Baltimore: Williams & Wilkins, 433-439
- 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 2475392Andersen JR, Sorensen SM, Kruse A, Rokkjaer M, Matzen P. Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice. Gut. 1989 Aug;30(8):1132-5. doi: 10.1136/gut.30.8.1132.
- Background: PubMed 1936809Motte S, Deviere J, Dumonceau JM, Serruys E, Thys JP, Cremer M. Risk factors for septicemia following endoscopic biliary stenting. Gastroenterology. 1991 Nov;101(5):1374-81. doi: 10.1016/0016-5085(91)90091-x.
- Background: PubMed 9013169Tarnasky PR, Cunningham JT, Hawes RH, Hoffman BJ, Uflacker R, Vujic I, Cotton PB. Transpapillary stenting of proximal biliary strictures: does biliary sphincterotomy reduce the risk of postprocedure pancreatitis? Gastrointest Endosc. 1997 Jan;45(1):46-51. doi: 10.1016/s0016-5107(97)70301-8.
- Background: PubMed 10343215Margulies C, Siqueira ES, Silverman WB, Lin XS, Martin JA, Rabinovitz M, Slivka A. The effect of endoscopic sphincterotomy on acute and chronic complications of biliary endoprostheses. Gastrointest Endosc. 1999 Jun;49(6):716-9. doi: 10.1016/s0016-5107(99)70288-9.
- Background: PubMed 15069728Giorgio PD, Luca LD. Comparison of treatment outcomes between biliary plastic stent placements with and without endoscopic sphincterotomy for inoperable malignant common bile duct obstruction. World J Gastroenterol. 2004 Apr 15;10(8):1212-4. doi: 10.3748/wjg.v10.i8.1212.
- Background: PubMed 1607087Johanson JF, Schmalz MJ, Geenen JE. Incidence and risk factors for biliary and pancreatic stent migration. Gastrointest Endosc. 1992 May-Jun;38(3):341-6. doi: 10.1016/s0016-5107(92)70429-5.
- Background: PubMed 2450501Speer AG, Cotton PB, Rode J, Seddon AM, Neal CR, Holton J, Costerton JW. Biliary stent blockage with bacterial biofilm. A light and electron microscopy study. Ann Intern Med. 1988 Apr;108(4):546-53. doi: 10.7326/0003-4819-108-4-546.
- Background: PubMed 8388345Frakes JT, Johanson JF, Stake JJ. Optimal timing for stent replacement in malignant biliary tract obstruction. Gastrointest Endosc. 1993 Mar-Apr;39(2):164-7. doi: 10.1016/s0016-5107(93)70058-9.
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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.
Stuart Sherman, MD principal investigator
Indiana University Medical Center
Glen A Lehman, MD principal investigator
Indiana Univesity Medical Center
James Frankes, MD principal investigator
Rockford GE Associates
Questions about this trial
What is this clinical trial studying?
A study testing ERCP with 10 French biliary plastic stent placement and ERCP with 11.5 French biliary plastic stent in people with Bile Duct Neoplasms Malignant, run by Indiana University.
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 1 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 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Documented change in Quality Of Life (time frame: 180 days after stent insertion). 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 NCT01459965, which also lists 37 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 26 Oct 2011.