SMAS: a Prospective Study in a Single Institution

Superior Mesenteric Artery Syndrome Clinical Trial

Official title:

Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416647
• Other study ID #: AOPadova
• Status: Completed
• Phase: N/A
• First received: December 18, 2017
• Last updated: January 24, 2018
• Start date: October 2008
• Est. completion date: February 2017

Study information

• Verified date: January 2018
• Source: Azienda Ospedaliera di Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, in order to describe their demographic, clinical and outcome features. All patients underwent duodenojejunostomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Mesenteric Ischemia
• Superior Mesenteric Artery Syndrome
• Syndrome

Intervention

Procedure:
• Duodenojejunostomy
Duodenojejunostomy with or without duodenal resection

Locations

Country	Name	City	State
Italy	General Surgery Unit	Padova	PD

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom score	Severity (0-6) + frequency (0-5) x 5 symptoms (abd pain, nausea, vomiting, reflux, bloating)	47 months (IQR 34-72)
Primary	BMI	Body mass index	47 months (IQR 34-72)
Primary	Need for medical treatment	PPIs, prokinetic drugs	47 months (IQR 34-72)