Pancreatic CancerNCT01569282
Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer
A study testing Hepaticojejunostomy and gastroenterostomy and Stent strategy in people with Pancreatic Cancer and Periampullary Tumor, run by Göteborg University at 6 sites in Sweden.
Trial summary
Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Cancer, Periampullary Tumor
- What is being tested?
- Hepaticojejunostomy and gastroenterostomy and Stent strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesSweden
- Study dates
- Oct 2011to 31 Oct 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperatively
- Patients with stent treated tumor in the pancreatic head or periampullary planned for pancreaticoduodenectomy
- The patient jaundice should have worn off and there should be no signs of duodenal obstruction
- The patient has given informed consent after verbal and written information in accordance with approved ethics application
- The patient has no anatomical conditions making endoscopic therapy impossible such as previous Billroth II or Gastric Bypass.
- Intraoperatively
Show all 9Show fewer
- Peroperative findings of of carcinomatosis, metastases or local irresectability who oppose radical surgery
- Surgical double bypass should be technically feasible
- The patient has given informed consent after verbal and written information in accordance with approved ethics application
Who cannot join
- Peroperative signs of dysfunction on biliary stent
- Peroperative findings of gastric outlet obstruction
- Surgical double bypass not technically feasible
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Department of Surgery, Sahlgrenska University Hospital
Gothenburg, 413 45
Department of surgery, University Hospital
Linköping
Department of Surgery, Skane University Hospital
Lund
Department of Surgery, University Hospital
Örebro
Gastro Center Surgery, Karolinska University Hospital
Stockholm
Department of Surgery, University Hospital
Umeå
About this study
Official title: Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study
Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible.
- Conditions
- Pancreatic Cancer, Periampullary Tumor
- Being tested
- Hepaticojejunostomy and gastroenterostomy, Stent strategy
- Keywords
- Surgical bypass, Hepaticojejunostomy, Gastrojejunostomy, Biliary stent, Enteral stent
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepaticojejunostomy and gastroenterostomyProcedure or surgery
Also called Biliodigestive anastomosis, Gastrojenunal anastomosis
Standard surgical techniques
Stent strategyProcedure or surgery
Also called Bile duct stent, Gastroduodenal stent, Enteral stent
Biliary and/or enteral stents on demand
| Study group | Role | What they receive |
|---|---|---|
| Double bypass | Active comparator | Not described Receives: Procedure: Hepaticojejunostomy and gastroenterostomy |
| Stent Strategy | Active comparator | Not described Receives: Procedure: Stent strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.
Measured: Day 1-30 after randomization
Secondary outcomes (3)
Quality of life
Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries
Measured: Preop, 1 month postop and every third month
Numbers of readmissions to hospital
Measured: Up to two years after the laparotomy
The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions
The numbers of surgical, radiological or endoscopical interventions due to jaundice or gastric outlet obstruction from date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months"
Measured: Up to 24 months after the randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startOct 2011
- Primary completion30 Apr 2015 (estimated)
- Study completion31 Oct 2015 (estimated)
Why it stopped: Difficulties to recruit patients
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.
- More trials run by Göteborg 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Fändriks, Professor, Study chair, Göteborg UniversityClaes Jönsson, Ass. Prof., Principal investigator, Gothenburg Universitity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569282
- Sponsor's protocol ID
- Double bypass vs Stent
- Status last verified
- Mar 2019
- First submitted
- 16 Mar 2012
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT01569282
- Acronym / sponsor ID
- Double bypass vs Stent
- Conditions
- Pancreatic Cancer, Periampullary Tumor
- Keywords
- Surgical bypass, Hepaticojejunostomy, Gastrojejunostomy, Biliary stent, Enteral stent
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- 30 Apr 2015 (estimated)
- Study completion
- 31 Oct 2015 (estimated)
- First posted
- 3 Apr 2012 (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.
Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double bypass | Active comparator | Procedure: Hepaticojejunostomy and gastroenterostomy |
| Stent Strategy | Active comparator | Procedure: Stent strategy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Preoperatively
- Intraoperatively
Key exclusion criteria (3 listed)
- Peroperative signs of dysfunction on biliary stent
- Peroperative findings of gastric outlet obstruction
- Surgical double bypass not technically feasible
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 |
|---|---|---|
| Hepaticojejunostomy and gastroenterostomyAlso: Biliodigestive anastomosis, Gastrojenunal anastomosisStandard surgical techniques | Procedure or surgery | Double bypass |
| Stent strategyAlso: Bile duct stent, Gastroduodenal stent, Enteral stentBiliary and/or enteral stents on demand | Procedure or surgery | Stent Strategy |
Primary outcome
Morbidity
Time frame: Day 1-30 after randomization
Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.
3 secondary outcomes
Quality of life
Time frame: Preop, 1 month postop and every third month
Numbers of readmissions to hospital
Time frame: Up to two years after the laparotomy
The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions
Time frame: Up to 24 months after the randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
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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.
Lars Fändriks, Professor study chair
Göteborg University
Claes Jönsson, Ass. Prof. principal investigator
Gothenburg Universitity
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepaticojejunostomy and gastroenterostomy and Stent strategy in people with Pancreatic Cancer and Periampullary Tumor, run by Göteborg University at 6 sites in Sweden.
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 9 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: withdrawn, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. 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 withdrawn before enrolling participants, so there are no results.
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?
Morbidity (time frame: Day 1-30 after randomization). 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 22 Mar 2019.