50 % Reduction of Delayed Gastric EmptyingPhase 2NCT02041052
The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
A Phase 2 study testing Subtotal gastrectomy as an adjunct to traditional whipple procedure. and Conventional whipple procedure in people with 50 % Reduction of Delayed Gastric Emptying, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
A small gastric remnant after whipple resection improves gastric emptying and therefore prevents the development of delayed gastric emptying. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- 50 % Reduction of Delayed Gastric Emptying
- What is being tested?
- Subtotal gastrectomy as an adjunct to traditional whipple procedure. and Conventional whipple procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to Dec 2014
- 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
- All patients undergoing whipple procedure with preoperative assignment as low risk for leakage from the pancreaticojejunal anastomosis.
- Signed informed consent.
Who cannot join
- High and intermediate risk pancreaticojejunal anastomosis. Unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Two Randomized Study of The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
A small gastric remnant after whipple resection improves gastric emptying and therefore prevents the development of delayed gastric emptying.
Read the detailed description
Every patient submitted to a whipple resection and at the same time present with characteristics suggestive of minimal risk for leakage from the pancreaticojejunostomy will be included in the study. At the time of reconstruction the patient will be randomized to either conventional size of the stomach or to a subtotal gastrectomy containing a small upper gastric pouch only.
- Being tested
- Subtotal gastrectomy as an adjunct to traditional whipple procedure., Conventional whipple procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtotal gastrectomy as an adjunct to traditional whipple procedure.Procedure or surgery
Subtotal gastrectomy as an adjunct to traditional whipple procedure.
Conventional whipple procedureProcedure or surgery
All patients undergoing whipple procedure without risk for pancreaticojejunal anastomosis leakage.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Whipple procedure | Active comparator | Conventional Whipple procedure Receives: Procedure: Conventional whipple procedure |
| Subtotal gastrectomy added to whipple procedure. | Experimental | Subtotal gastrectomy added to Whipple procedure. Receives: Procedure: Subtotal gastrectomy as an adjunct to traditional whipple procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delayed gastric emptying
During the postoperative phase the patient will be followed daily with assessment of symptoms suggestive of delayed gastric emptying.
Measured: Postoperative recovery period in days (on an average <20 days)
Secondary outcomes (3)
Quality of life
Quality of life measured by use of scientifically validated instruments.
Measured: during three first postoperative months
Postoperative hospital stay
Time in days from the operation to discharge from hospital.
Measured: In hospital stay in days (on an average <20 days)
Total Gastric emptying as measured by the paracetamol test
Paracetamol orally ingested together with chocolate biscuits whereafter peripheral venous blood concentrations of paracetamol are determined. Blood samples taken at baseline and every 15 minutes after paracetamol ingestion during the first hour and then every 30 minutes for an hour.
Measured: three months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Terminated due to insufficient inclusion rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 50 % Reduction of Delayed Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Karolinska 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ralf Segersvärd, Afshin Noorani, John Blomberg
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
- Investigators
- Lars Lundell, professor, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041052
- Sponsor's protocol ID
- 2011/1262-31/3
- Other IDs
- 2011/1262-31/3
- Status last verified
- Jan 2017
- First submitted
- 10 Dec 2013
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Two Randomized Study of The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
- ClinicalTrials.gov ID
- NCT02041052
- Acronym / sponsor ID
- 2011/1262-31/3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to insufficient inclusion rate.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Ralf Segersvärd, Afshin Noorani, John Blomberg
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Jan 2014 (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.
A small gastric remnant after whipple resection improves gastric emptying and therefore prevents the development of delayed gastric emptying.
Detailed description
Every patient submitted to a whipple resection and at the same time present with characteristics suggestive of minimal risk for leakage from the pancreaticojejunostomy will be included in the study. At the time of reconstruction the patient will be randomized to either conventional size of the stomach or to a subtotal gastrectomy containing a small upper gastric pouch only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Whipple procedure | Active comparator | Procedure: Conventional whipple procedureConventional Whipple procedure |
| Subtotal gastrectomy added to whipple procedure. | Experimental | Procedure: Subtotal gastrectomy as an adjunct to traditional whipple procedure.Subtotal gastrectomy added to Whipple procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing whipple procedure with preoperative assignment as low risk for leakage from the pancreaticojejunal anastomosis.
- Signed informed consent.
Key exclusion criteria (1 listed)
- High and intermediate risk pancreaticojejunal anastomosis. Unwillingness to participate.
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 |
|---|---|---|
| Subtotal gastrectomy as an adjunct to traditional whipple procedure.Subtotal gastrectomy as an adjunct to traditional whipple procedure. | Procedure or surgery | Subtotal gastrectomy added to whipple procedure. |
| Conventional whipple procedureAll patients undergoing whipple procedure without risk for pancreaticojejunal anastomosis leakage. | Procedure or surgery | Conventional Whipple procedure |
Primary outcome
Postoperative delayed gastric emptying
Time frame: Postoperative recovery period in days (on an average <20 days)
During the postoperative phase the patient will be followed daily with assessment of symptoms suggestive of delayed gastric emptying.
3 secondary outcomes
Quality of life
Time frame: during three first postoperative months
Postoperative hospital stay
Time frame: In hospital stay in days (on an average <20 days)
Total Gastric emptying as measured by the paracetamol test
Time frame: three months postoperatively
Results and safety
The study was stopped early (reason given: Terminated due to insufficient inclusion rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
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 Lundell, professor principal investigator
Karolinska University Hospital
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 Subtotal gastrectomy as an adjunct to traditional whipple procedure. and Conventional whipple procedure in people with 50 % Reduction of Delayed Gastric Emptying, run by Karolinska University Hospital 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 1 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 5 Jan 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 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 stopped early (reason given: Terminated due to insufficient inclusion rate.). 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?
Postoperative delayed gastric emptying (time frame: Postoperative recovery period in days (on an average <20 days)). 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 5 Jan 2017.