Pancreatic CancerSTENTBYNCT00753441
Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head
A study testing Surgical bypass and Endoscopic stenting in people with Pancreatic Cancer, run by Heidelberg University at 1 site in Germany.
Trial summary
The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Surgical bypass and Endoscopic stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2009to 16 Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal or greater than 18 years
- Diagnosis of unresectable cancer of the pancreatic head (after clinical, laboratory, radiological assessment) requiring palliative treatment for biliary obstruction. In unclear cases an exploratory laparotomy will be performed and resectability will be evaluated intraoperatively
- Operability certified by anesthesiologist
- Written informed consent
Who cannot join
- Intervention technically/medically not feasible
- Expected lack of compliance
- One treatment option considered to be clearly in favor of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Biliary Stenting on Demand Versus Surgical Biliary Bypass for Palliation of Patients With Advanced Cancer of the Pancreatic Head: STENTBY - A Randomized Controlled Trial
The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting and surgical bypass are currently the two competing treatment options. There is currently no randomized trial comparing the recently developed metal stents to surgical bypass. Furthermore, there is very limited data on quality of life of these patients receiving either therapy. While endoscopic stenting represents the less invasive treatment, surgery may provide better long-term control requiring one-time treatment. Due to the incomplete evidence the present randomized controlled trial is designed to compare quality of life of patients undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused by cancer of the pancreatic head requiring with low bile duct obstruction.
- Conditions
- Pancreatic Cancer
- Being tested
- Surgical bypass, Endoscopic stenting
- Keywords
- Pancreatic cancer, Bile duct obstruction, Stent, Bypass
- Medical subject headings
- Pancreatic Neoplasms, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical bypassProcedure or surgery
Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
Endoscopic stentingProcedure or surgery
Placement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary) Receives: Procedure: Surgical bypass |
| B | Active comparator | Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary) Receives: Procedure: Endoscopic stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: 12 months
Serum bilirubin
Measured: 12 months
Secondary outcomes (1)
Procedure-related complications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study start1 Feb 2009
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
Why it stopped: Low patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuh Rahbari, Heidelberg University
- Investigators
- Bruno Schmied, MD, Principal investigator, Department of General, Visceral and Transplantation Surgery, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753441
- Sponsor's protocol ID
- NNR-02
- Acronym
- STENTBY
- Status last verified
- Oct 2017
- First submitted
- 15 Sep 2008
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Biliary Stenting on Demand Versus Surgical Biliary Bypass for Palliation of Patients With Advanced Cancer of the Pancreatic Head: STENTBY - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00753441
- Acronym / sponsor ID
- STENTBY / NNR-02
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Bile duct obstruction, Stent, Bypass
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low patient accrual
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 1 Feb 2009 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 16 Sep 2008 (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.
The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting and surgical bypass are currently the two competing treatment options. There is currently no randomized trial comparing the recently developed metal stents to surgical bypass. Furthermore, there is very limited data on quality of life of these patients receiving either therapy. While endoscopic stenting represents the less invasive treatment, surgery may provide better long-term control requiring one-time treatment. Due to the incomplete evidence the present randomized controlled trial is designed to compare quality of life of patients undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused by cancer of the pancreatic head requiring with low bile duct obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Surgical bypassSurgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary) |
| B | Active comparator | Procedure: Endoscopic stentingEndoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age equal or greater than 18 years
- Diagnosis of unresectable cancer of the pancreatic head (after clinical, laboratory, radiological assessment) requiring palliative treatment for biliary obstruction. In unclear cases an exploratory laparotomy will be performed and resectability will be evaluated intraoperatively
- Operability certified by anesthesiologist
- Written informed consent
Key exclusion criteria (3 listed)
- Intervention technically/medically not feasible
- Expected lack of compliance
- One treatment option considered to be clearly in favor of the patient
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 |
|---|---|---|
| Surgical bypassSurgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary) | Procedure or surgery | A |
| Endoscopic stentingPlacement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary) | Procedure or surgery | B |
Primary outcome
Quality of life
Time frame: 12 months
Serum bilirubin
Time frame: 12 months
1 secondary outcome
Procedure-related complications
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Low patient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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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.
Bruno Schmied, MD principal investigator
Department of General, Visceral and Transplantation Surgery, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical bypass and Endoscopic stenting in people with Pancreatic Cancer, run by Heidelberg University at 1 site in Germany.
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 4 inclusion and 3 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 27 Oct 2017. 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 Germany. 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: Low patient accrual). 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?
Quality of life (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2017.