Clincosm LogoSign in Get a demo

Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet

Sponsor
Region Skane (Other)
Overall Status
Completed
CT.gov ID
NCT02158286
Collaborator
(none)
13
Enrollment
1
Location
26
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retention of the gastric tube after esophagectomy is a clinically important problem, and there is a need of a simple method to evaluate emptying rate from the gastric tube after esophagectomy. Scintigraphy is the golden standard of measuring emptying rate from the gastric tube. In non-operated patients, paracetamol clearance technique have been widely used for measuring gastric emptying rate. There is no validation however if paracetamol clearance technique can be used for measuring emptying rate of the gastric tube. The investigators aim of this pilot- study is to validate paracetamol clearance technique to scintigraphy for measuring emptying rate from the gastric tube and to evaluate if there is a correlation between symptoms of retention and quality of life with the emptying rate.

Condition or Disease Intervention/Treatment Phase
  • Other: Measuring emptying rate from the gastric tube

Study Design

Study Type:
Observational
Actual Enrollment :
13 participants
Observational Model:
Case-Only
Official Title:
Validation of Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet to Golden Standard, to Scintigraphy. A Pilot Study
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Esophagectomy, Emptying from gastric tube

Validate paracetamol clearance technique to scintigraphy for measuring emptying rate from the gastric tube.

Other: Measuring emptying rate from the gastric tube
Other Names:
  • Paracetamol clearance technique
  • Scintigraphy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Validate paracetamol clearance technique to scintigraphy for measuring emptying rate from the gastric tube [Up to 12 months]

      During one diagnostic measurement perform, simultaneously, scintigraphy and paracetamol clearance technique to measure emptying rate from the gastric tube. After the test the patient answer both a QOL questionnaire and symptom questionnaire.

    Secondary Outcome Measures

    1. Evaluate if patient with symptoms of slow emptying rate from the gastric tube also have slow emptying rate measured with scintigraphy. [Up to 12 months]

      Patients will answer the questionaire EORTC QLQ OG25 for validation of upper gastrointestinal symptoms and the questionnaire EORTC QLQ C30 for validation of quality of life. Emptying rate from the gastric tube is measured with scintigraphy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients where it had past at least two years since they had underwent an Ivor Lewis esophagectomy with gastric pull-up reconstruction.

    • no signs of recurrence

    • 18 years of age

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Surgery Lund Sweden 22185

    Sponsors and Collaborators

    • Region Skane

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Region Skane
    ClinicalTrials.gov Identifier:
    NCT02158286
    Other Study ID Numbers:
    • TS2010
    First Posted:
    Jun 6, 2014
    Last Update Posted:
    Jun 6, 2014
    Last Verified:
    May 1, 2014
    Additional relevant MeSH terms:
    Acetaminophen

    Study Results

    No Results Posted as of Jun 6, 2014