NCT03416647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

7.6 years

First QC Date

December 18, 2017

Last Update Submit

January 24, 2018

Conditions

Superior Mesenteric Artery Syndrome

Keywords

Superior Mesenteric Artery SyndromeChronic duodenal obstructionDuodenojejunostomyWilkie's syndrome

Outcome Measures

Primary Outcomes (3)

  • Symptom score

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

    47 months (IQR 34-72)

  • BMI

    Body mass index

    47 months (IQR 34-72)

  • Need for medical treatment

    PPIs, prokinetic drugs

    47 months (IQR 34-72)

Study Arms (1)

SMAS patients

EXPERIMENTAL
Procedure: Duodenojejunostomy

Interventions

DuodenojejunostomyPROCEDURE

Duodenojejunostomy with or without duodenal resection

SMAS patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • inability to provide the informed consent;
  • malignancies;
  • bowel motility disorders;
  • severe psychiatric illness;
  • pregnancy;
  • impossibility to perform the required diagnostic workup.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Surgery Unit

Padua, PD, 35128, Italy

Location

Related Publications (1)

  • 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.

    PMID: 30291587DERIVED

MeSH Terms

Conditions

Superior Mesenteric Artery Syndrome

Condition Hierarchy (Ancestors)

Duodenal ObstructionDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Angelica Ganss, M.D.

    General Surgery Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 31, 2018

Study Start

October 1, 2008

Primary Completion

May 1, 2016

Study Completion

February 1, 2017

Last Updated

January 31, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)