Superior Mesenteric Artery SyndromeNCT03416647
SMAS: a Prospective Study in a Single Institution
A study testing Duodenojejunostomy in people with Superior Mesenteric Artery Syndrome, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
Superior Mesenteric Artery Syndrome (SMAS) is a rare cause of duodenal obstruction, that should be suspected in cases of chronic, refractory upper digestive symptoms. Between 2008 and 2016, 39 consecutive patients with chronic gastrointestinal symptoms and a diagnosis of SMAS were prospectively included in the study… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Superior Mesenteric Artery Syndrome
- What is being tested?
- Duodenojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2008to Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- severe and frequent upper digestive symptoms (occurring at least once a week), associated to poor quality of life and refractory response to medical treatment;
- a condition of underweight (BMI <18.5 kg/m2) associated with difficulty eating;
- severe complications of SMAS (e.g. gastric perforation, acute pancreatitis, aspiration pneumonia);
- suggestive findings of SMAS at barium swallow;
- diagnostic aortomesenteric angle and distance at CT/MR angiography.
Who cannot join
- inability to provide the informed consent;
- malignancies;
- bowel motility disorders;
- severe psychiatric illness;
- pregnancy;
- impossibility to perform the required diagnostic workup.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution
Superior Mesenteric Artery Syndrome (SMAS) is a rare cause of duodenal obstruction, that should be suspected in cases of chronic, refractory upper digestive symptoms. Between 2008 and 2016, 39 consecutive patients with chronic gastrointestinal symptoms and a diagnosis of SMAS were prospectively included in the study, in order to describe their demographic, clinical and outcome features. All patients underwent duodenojejunostomy.
- Conditions
- Superior Mesenteric Artery Syndrome
- Being tested
- Duodenojejunostomy
- Keywords
- Superior Mesenteric Artery Syndrome, Chronic duodenal obstruction, Duodenojejunostomy, Wilkie's syndrome
- Medical subject headings
- Superior Mesenteric Artery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuodenojejunostomyProcedure or surgery
Duodenojejunostomy with or without duodenal resection
| Study group | Role | What they receive |
|---|---|---|
| SMAS patients | Experimental | Not described Receives: Procedure: Duodenojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom score
Severity (0-6) + frequency (0-5) x 5 symptoms (abd pain, nausea, vomiting, reflux, bloating)
Measured: 47 months (IQR 34-72)
BMI
Body mass index
Measured: 47 months (IQR 34-72)
Need for medical treatment
PPIs, prokinetic drugs
Measured: 47 months (IQR 34-72)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study startOct 2008
- Primary completionMay 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Superior Mesenteric Artery SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelica Ganss, Azienda Ospedaliera di Padova
- Investigators
- Angelica Ganss, M.D., Principal investigator, General Surgery Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416647
- Sponsor's protocol ID
- AOPadova
- Status last verified
- Jan 2018
- First submitted
- 18 Dec 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ganss A, Rampado S, Savarino E, Bardini R. Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution. J Gastrointest Surg. 2019 May;23(5):997-1005. doi: 10.1007/s11605-018-3984-6. Epub 2018 Oct 5.
PubMed 30291587
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution
- ClinicalTrials.gov ID
- NCT03416647
- Acronym / sponsor ID
- AOPadova
- Conditions
- Superior Mesenteric Artery Syndrome
- Keywords
- Superior Mesenteric Artery Syndrome, Chronic duodenal obstruction, Duodenojejunostomy, Wilkie's syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 31 Jan 2018 (actual)
- 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.
Superior Mesenteric Artery Syndrome (SMAS) is a rare cause of duodenal obstruction, that should be suspected in cases of chronic, refractory upper digestive symptoms. Between 2008 and 2016, 39 consecutive patients with chronic gastrointestinal symptoms and a diagnosis of SMAS were prospectively included in the study, in order to describe their demographic, clinical and outcome features. All patients underwent duodenojejunostomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMAS patients | Experimental | Procedure: Duodenojejunostomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- severe and frequent upper digestive symptoms (occurring at least once a week), associated to poor quality of life and refractory response to medical treatment;
- a condition of underweight (BMI <18.5 kg/m2) associated with difficulty eating;
- severe complications of SMAS (e.g. gastric perforation, acute pancreatitis, aspiration pneumonia);
- suggestive findings of SMAS at barium swallow;
- diagnostic aortomesenteric angle and distance at CT/MR angiography.
Key exclusion criteria (6 listed)
- inability to provide the informed consent;
- malignancies;
- bowel motility disorders;
- severe psychiatric illness;
- pregnancy;
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 |
|---|---|---|
| DuodenojejunostomyDuodenojejunostomy with or without duodenal resection | Procedure or surgery | SMAS patients |
Primary outcome
Symptom score
Time frame: 47 months (IQR 34-72)
Severity (0-6) + frequency (0-5) x 5 symptoms (abd pain, nausea, vomiting, reflux, bloating)
BMI
Time frame: 47 months (IQR 34-72)
Body mass index
Need for medical treatment
Time frame: 47 months (IQR 34-72)
PPIs, prokinetic drugs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Derived from this study: PubMed 30291587Ganss A, Rampado S, Savarino E, Bardini R. Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution. J Gastrointest Surg. 2019 May;23(5):997-1005. doi: 10.1007/s11605-018-3984-6. Epub 2018 Oct 5.
- Individual participant dataSharing planned: No
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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.
Angelica Ganss, M.D. principal investigator
General Surgery Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duodenojejunostomy in people with Superior Mesenteric Artery Syndrome, run by Azienda Ospedaliera di Padova at 1 site in Italy.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 31 Jan 2018. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptom score (time frame: 47 months (IQR 34-72)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03416647, which also lists 1 linked publication.
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 31 Jan 2018.