Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet

June 4, 2014 updated by: Region Skane

Validation of Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet to Golden Standard, to Scintigraphy. A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 22185
        • Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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:
  • Scintigraphy
  • Paracetamol clearance technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (ESTIMATE)

June 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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