Pylorus Dysfunction After Esophagectomy and Gastric Tube Reconstruction. Effect of Pneumatic Pylorus Dilatation During Hospital Stay, Surgical Complications During in Hospital Stay

Esophagectomy Clinical Trial

Official title:

Pylorus Dysfunction After Esophagectomy. Effect of Pneumatic Dilatation.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02086461
• Other study ID #: 2013/896-31/4
• Secondary ID: 2013/896-31/4
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem. No treatment is currently available. It can be hypothesized that incomplete relaxation of the pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may therefore be a potentially effective treatment.

Description:

Patients surviving one year after esophagectomy are sent questionnaires to pick up symptoms suggestive of delayed gastric emptying.Those fulfilling predefined criteria for delayed gastric emptying will be invited to the study. The study design is sham controlled single blind with a follow up extending to twelve months post treatment.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Previous esophagectomy and gastric tube reconstruction.

• Symptoms suggestive of delayed gastric emptying.

• signed informed consent

Exclusion Criteria:

• Signs of recurrent cancer disease

• no symptoms suggestive of delayed gastric emptying.

• unwillingness to participate

Related Conditions & MeSH terms

• Delayed Gastric Emptying
• Esophagectomy
• Gastroparesis
• No Signs of Cancer Recurrence
• Recurrence

Intervention

Device:
• Pneumatic pyloric dilatation

Other:
• 15 mm pyloric balloon dilatation

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (6)

Lead Sponsor	Collaborator
Karolinska University Hospital	Lund University Hospital, Region Örebro County, Sahlgrenska University Hospital, Sweden, University Hospital, Linkoeping, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms suggestive of delayed gastric emptying	Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation.	3-12 months after treatment
Secondary	Quality of Life	Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation.	3-12 months after treatment.
Secondary	Delayed gastric emptying	Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation. Paracetamol test done only 3 months after treatment.	3, 6 and 12 months after treatment.