Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet

NCT02158286 | Completed

• 1 other identifier: TS2010
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (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

Study Arms (1)

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

Interventions

Measuring emptying rate from the gastric tube OTHER

Also known as: Paracetamol clearance technique, Scintigraphy

Esophagectomy, Emptying from gastric tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Surgery

Lund, 22185, Sweden

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 6, 2014
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: March 1, 2014
• Last Updated: June 6, 2014

Record last verified: 2014-05

Locations

SE (1)