Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet

Esophagectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158286
• Other study ID #: TS2010
• Status: Completed
• Phase: N/A
• First received: June 2, 2014
• Last updated: June 4, 2014
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only

Related Conditions & MeSH terms

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

Intervention

Other:
• Measuring emptying rate from the gastric tube

Locations

Country	Name	City	State
Sweden	Department of Surgery	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate paracetamol clearance technique to scintigraphy for measuring emptying rate from the gastric tube	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	No
Secondary	Evaluate if patient with symptoms of slow emptying rate from the gastric tube also have slow emptying rate measured with scintigraphy.	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	No