Pancreatic NeoplasmsPhase 2NCT00487851
Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer
A Phase 2 study testing surgery and endoscopic strategy in people with Pancreatic Neoplasms and Biliary Tract Neoplasms, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Neoplasms, Biliary Tract Neoplasms, Duodenal Neoplasms
- What is being tested?
- surgery and endoscopic strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2007to Dec 2012
- Phase
- Phase 2
- 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 a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction.
- The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable".
Who cannot join
- Non consent.
- The patients' general condition will not tolerate either treatment (strategy).
- Previous laparotomy or laparoscopy.
- Life expectancy < 3 months.
- Inability to participate (language, social, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer
Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer
Read the detailed description
Experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. Ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. This operation was often associated with a high morbidity. Developments in endoscopic treatments allow palliation with lower morbidity. However, stent treatment is not free of problems like stent dysfunction. During the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. A total of 70 patients were randomized to surgery with hepaticojejunostomy on Roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.
- Being tested
- surgery, endoscopic strategy
- Keywords
- Pancreatic, cancer, Periampullay, Neoplasms, Biliary, Duodenal, Jaundice, obstruction, pancreas cancer, Pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms, Duodenal Neoplasms, Neoplasms, Jaundice, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
hepaticojejunostomy and gastroenterostomy
endoscopic strategyProcedure or surgery
Stent insertion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Endoscopic treatment strategy Receives: Procedure: endoscopic strategy |
| 2 | Active comparator | Surgical treatment strategy Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome consist of a composite score (i.e. number of hospitalizations, episodes of cholangitis, degree of jaundice, other complications requiring therapeutic interventions). Secondary outcome are QoL,hospital stay and health economic burden.
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2012 (estimated)
- Study completionDec 2012
Why it stopped: Withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farshad Frozanpor, Karolinska Institutet
- Investigators
- Farshad Frozanpor, Principal investigator, Karolinska institut Huddinge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487851
- Sponsor's protocol ID
- 2006/2:3
- Status last verified
- Apr 2013
- First submitted
- 18 Jun 2007
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer
- ClinicalTrials.gov ID
- NCT00487851
- Acronym / sponsor ID
- 2006/2:3
- Keywords
- Pancreatic, cancer, Periampullay, Neoplasms, Biliary, Duodenal, Jaundice, obstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Jun 2007 (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.
Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer
Detailed description
Experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. Ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. This operation was often associated with a high morbidity. Developments in endoscopic treatments allow palliation with lower morbidity. However, stent treatment is not free of problems like stent dysfunction. During the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. A total of 70 patients were randomized to surgery with hepaticojejunostomy on Roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: endoscopic strategyEndoscopic treatment strategy |
| 2 | Active comparator | Procedure: surgerySurgical treatment strategy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction.
- The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable".
Key exclusion criteria (5 listed)
- Non consent.
- The patients' general condition will not tolerate either treatment (strategy).
- Previous laparotomy or laparoscopy.
- Life expectancy < 3 months.
- Inability to participate (language, social, etc.)
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 |
|---|---|---|
| surgeryhepaticojejunostomy and gastroenterostomy | Procedure or surgery | 2 |
| endoscopic strategyStent insertion | Procedure or surgery | 1 |
Primary outcome
Primary outcome consist of a composite score (i.e. number of hospitalizations, episodes of cholangitis, degree of jaundice, other complications requiring therapeutic interventions). Secondary outcome are QoL,hospital stay and health economic burden.
Time frame: 1, 3 and 6 months
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 12 Apr 2013.
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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.
Farshad Frozanpor principal investigator
Karolinska institut Huddinge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing surgery and endoscopic strategy in people with Pancreatic Neoplasms and Biliary Tract Neoplasms, run by Karolinska Institutet at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 12 Apr 2013. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary outcome consist of a composite score (i.e. number of hospitalizations, episodes of cholangitis, degree of jaundice, other complications requiring therapeutic interventions). Secondary outcome are QoL,hospital stay and health economic burden. (time frame: 1, 3 and 6 months). 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 12 Apr 2013.