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

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Pylorus Dysfunction After Esophagectomy. Effect of Pneumatic Dilatation.

Conditions
-----------------
Esophagectomy, No Signs of Cancer Recurrence, Delayed Gastric Emptying

Intervention / Treatment
-----------------
* Device: Pneumatic pyloric dilatation
* Other: 15 mm pyloric balloon dilatation


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 15 mm Pyloric balloon dilatation.<br>During fluoroscopic control the pneumatic balloon is positioned of the pyloric sphincter and maintained there during the entire dilatation. | Other: 15 mm pyloric balloon dilatation<br> <br> |
| Active Comparator: Pneumatic pyloric dilatation.<br>Endoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm. | Device: Pneumatic pyloric dilatation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. |