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Trial record 6 of 82931 for:    measured

Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet

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: NCT02158286
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
Region Skane

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
Esophageal and/or Cardia Cancer Esophagectomy Gastric Pull-up Reconstruction Other: Measuring emptying rate from the gastric tube

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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 : January 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Group/Cohort 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




Primary Outcome Measures :
  1. Validate paracetamol clearance technique to scintigraphy for measuring emptying rate from the gastric tube [ Time Frame: 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. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients where it had past at least two years since they had underwent an Ivor Lewis esophagectomy with gastric pull-up reconstruction.
Criteria

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:

-


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): NCT02158286


Locations
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Sweden
Department of Surgery
Lund, Sweden, 22185
Sponsors and Collaborators
Region Skane

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT02158286    
Other Study ID Numbers: TS2010
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics