Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet

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.

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Key information

Conditions

Esophageal and/or Cardia Cancer Esophagectomy Gastric Pull-up Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery

Lund, 22185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measuring emptying rate from the gastric tube

Other

Other names: Paracetamol clearance technique, Scintigraphy

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Jun 6, 2014
Registry last updated: Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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