Back to resultsSMAS: a Prospective Study in a Single Institution
Primary Purpose
Superior Mesenteric Artery Syndrome
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Duodenojejunostomy
Sponsored by
About this trial
This is an interventional treatment trial for Superior Mesenteric Artery Syndrome focused on measuring Superior Mesenteric Artery Syndrome, Chronic duodenal obstruction, Duodenojejunostomy, Wilkie's syndrome
Eligibility Criteria
Inclusion Criteria (at least 2 of the following):
- 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.
Exclusion Criteria:
- inability to provide the informed consent;
- malignancies;
- bowel motility disorders;
- severe psychiatric illness;
- pregnancy;
- impossibility to perform the required diagnostic workup.
Sites / Locations
- General Surgery Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMAS patients
Arm Description
Outcomes
Primary Outcome Measures
Symptom score
Severity (0-6) + frequency (0-5) x 5 symptoms (abd pain, nausea, vomiting, reflux, bloating)
BMI
Body mass index
Need for medical treatment
PPIs, prokinetic drugs
Secondary Outcome Measures
Full Information
NCT ID
NCT03416647
First Posted
December 18, 2017
Last Updated
January 24, 2018
Sponsor
Azienda Ospedaliera di Padova
1. Study Identification
Unique Protocol Identification Number
NCT03416647
Brief Title
SMAS: a Prospective Study in a Single Institution
Official Title
Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera di Padova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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, in order to describe their demographic, clinical and outcome features. All patients underwent duodenojejunostomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superior Mesenteric Artery Syndrome
Keywords
Superior Mesenteric Artery Syndrome, Chronic duodenal obstruction, Duodenojejunostomy, Wilkie's syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMAS patients
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Duodenojejunostomy
Intervention Description
Duodenojejunostomy with or without duodenal resection
Primary Outcome Measure Information:
Title
Symptom score
Description
Severity (0-6) + frequency (0-5) x 5 symptoms (abd pain, nausea, vomiting, reflux, bloating)
Time Frame
47 months (IQR 34-72)
Title
BMI
Description
Body mass index
Time Frame
47 months (IQR 34-72)
Title
Need for medical treatment
Description
PPIs, prokinetic drugs
Time Frame
47 months (IQR 34-72)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (at least 2 of the following):
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.
Exclusion Criteria:
inability to provide the informed consent;
malignancies;
bowel motility disorders;
severe psychiatric illness;
pregnancy;
impossibility to perform the required diagnostic workup.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelica Ganss, M.D.
Organizational Affiliation
General Surgery Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Surgery Unit
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30291587
Citation
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.
Results Reference
derived
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SMAS: a Prospective Study in a Single Institution
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