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OpenTrials
Completed

NCT Number: NCT03416647

SMAS: 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.

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Key information

Conditions

Superior Mesenteric Artery Syndrome Digestive System Diseases Duodenal Diseases Duodenal Obstruction Gastrointestinal Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Surgery Unit

Padova, PD, 35128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duodenojejunostomy

Procedure

Duodenojejunostomy with or without duodenal resection

Primary outcomes

  1. Symptom score

    Time frame: 47 months (IQR 34-72)

    Severity (0-6) + frequency (0-5) x 5 symptoms (abd pain, nausea, vomiting, reflux, bloating)

  2. BMI

    Time frame: 47 months (IQR 34-72)

    Body mass index

  3. Need for medical treatment

    Time frame: 47 months (IQR 34-72)

    PPIs, prokinetic drugs

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2016
Study completion
2017
First posted
Jan 31, 2018
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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