EsophagectomyNCT02086461
Pylorus Dysfunction After Esophagectomy and Gastric Tube Reconstruction. Effect of Pneumatic Pylorus Dilatation During Hospital Stay, Surgical Complications During in Hospital Stay
A study testing Pneumatic pyloric dilatation and 15 mm pyloric balloon dilatation in people with Esophagectomy and No Signs of Cancer Recurrence, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem. No treatment is currently available. It can be hypothesized that incomplete relaxation of the pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may therefore be a potentially effective treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophagectomy, No Signs of Cancer Recurrence, Delayed Gastric Emptying
- What is being tested?
- Pneumatic pyloric dilatation and 15 mm pyloric balloon dilatation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- May 2014to Dec 2020
- 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
- Previous esophagectomy and gastric tube reconstruction.
- Symptoms suggestive of delayed gastric emptying.
- signed informed consent
Who cannot join
- Signs of recurrent cancer disease
- no symptoms suggestive of delayed gastric emptying.
- unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pylorus Dysfunction After Esophagectomy. Effect of Pneumatic Dilatation.
Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem. No treatment is currently available. It can be hypothesized that incomplete relaxation of the pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may therefore be a potentially effective treatment.
Read the detailed description
Patients surviving one year after esophagectomy are sent questionnaires to pick up symptoms suggestive of delayed gastric emptying.Those fulfilling predefined criteria for delayed gastric emptying will be invited to the study. The study design is sham controlled single blind with a follow up extending to twelve months post treatment.
- Being tested
- Pneumatic pyloric dilatation, 15 mm pyloric balloon dilatation
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic pyloric dilatationDevice
15 mm pyloric balloon dilatationOther
| Study group | Role | What they receive |
|---|---|---|
| 15 mm Pyloric balloon dilatation. | Sham comparator | During fluoroscopic control the pneumatic balloon is positioned of the pyloric sphincter and maintained there during the entire dilatation. Receives: Other: 15 mm pyloric balloon dilatation |
| Pneumatic pyloric dilatation. | Active comparator | Endoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm. Receives: Device: Pneumatic pyloric dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms suggestive of delayed gastric emptying
Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation.
Measured: 3-12 months after treatment
Secondary outcomes (2)
Quality of Life
Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation.
Measured: 3-12 months after treatment.
Delayed gastric emptying
Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation. Paracetamol test done only 3 months after treatment.
Measured: 3, 6 and 12 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagectomyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University Hospital, Sahlgrenska University Hospital, Region Örebro County, Uppsala University Hospital, University Hospital, Linkoeping
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
- Investigators
- Jon Tsai, ass professor, Principal investigator, Karolinska University Hospital, Gastrocentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086461
- Sponsor's protocol ID
- 2013/896-31/4
- Other IDs
- 2013/896-31/4
- Status last verified
- Jan 2019
- First submitted
- 11 Mar 2014
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pylorus Dysfunction After Esophagectomy. Effect of Pneumatic Dilatation.
- ClinicalTrials.gov ID
- NCT02086461
- Acronym / sponsor ID
- 2013/896-31/4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Lund University Hospital, Sahlgrenska University Hospital, Region Örebro County, Uppsala University Hospital, University Hospital, Linkoeping
- Study start
- May 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Mar 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.
Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem. No treatment is currently available. It can be hypothesized that incomplete relaxation of the pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may therefore be a potentially effective treatment.
Detailed description
Patients surviving one year after esophagectomy are sent questionnaires to pick up symptoms suggestive of delayed gastric emptying.Those fulfilling predefined criteria for delayed gastric emptying will be invited to the study. The study design is sham controlled single blind with a follow up extending to twelve months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15 mm Pyloric balloon dilatation. | Sham comparator | Other: 15 mm pyloric balloon dilatationDuring fluoroscopic control the pneumatic balloon is positioned of the pyloric sphincter and maintained there during the entire dilatation. |
| Pneumatic pyloric dilatation. | Active comparator | Device: Pneumatic pyloric dilatationEndoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Previous esophagectomy and gastric tube reconstruction.
- Symptoms suggestive of delayed gastric emptying.
- signed informed consent
Key exclusion criteria (3 listed)
- Signs of recurrent cancer disease
- no symptoms suggestive of delayed gastric emptying.
- 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 |
|---|---|---|
| Pneumatic pyloric dilatation | Device | Pneumatic pyloric dilatation. |
| 15 mm pyloric balloon dilatation | Other | 15 mm Pyloric balloon dilatation. |
Primary outcome
Symptoms suggestive of delayed gastric emptying
Time frame: 3-12 months after treatment
Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation.
2 secondary outcomes
Quality of Life
Time frame: 3-12 months after treatment.
Delayed gastric emptying
Time frame: 3, 6 and 12 months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 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.
Jon Tsai, ass professor principal investigator
Karolinska University Hospital, Gastrocentrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic pyloric dilatation and 15 mm pyloric balloon dilatation in people with Esophagectomy and No Signs of Cancer Recurrence, 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 3 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: status not confirmed, as of the sponsor's last update on 3 Jan 2019. 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. Some participants in this study may receive a placebo. 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?
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?
Symptoms suggestive of delayed gastric emptying (time frame: 3-12 months after treatment). 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 3 Jan 2019.