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SMAS: a Prospective Study in a Single Institution

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416647
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Angelica Ganss, Azienda Ospedaliera di Padova

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.

Condition or disease Intervention/treatment Phase
Superior Mesenteric Artery Syndrome Procedure: Duodenojejunostomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution
Study Start Date : October 2008
Actual Primary Completion Date : May 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SMAS patients Procedure: Duodenojejunostomy
Duodenojejunostomy with or without duodenal resection




Primary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416647


Locations
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Italy
General Surgery Unit
Padova, PD, Italy, 35128
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Investigators
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Principal Investigator: Angelica Ganss, M.D. General Surgery Unit
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Angelica Ganss, Principal Investigator, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT03416647    
Other Study ID Numbers: AOPadova
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angelica Ganss, Azienda Ospedaliera di Padova:
Superior Mesenteric Artery Syndrome
Chronic duodenal obstruction
Duodenojejunostomy
Wilkie's syndrome
Additional relevant MeSH terms:
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Superior Mesenteric Artery Syndrome
Mesenteric Ischemia
Syndrome
Disease
Pathologic Processes
Duodenal Obstruction
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases
Vascular Diseases
Cardiovascular Diseases