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

Not Applicable

• Conditions: Esophagectomy; Delayed Gastric Emptying; No Signs of Cancer Recurrence
• Interventions: Other: 15 mm pyloric balloon dilatation; Device: Pneumatic pyloric dilatation

• Registration Number: NCT02086461
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Study Start: 2014-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-03
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 mm Pyloric balloon dilatation.	15 mm pyloric balloon dilatation	During fluoroscopic control the pneumatic balloon is positioned of the pyloric sphincter and maintained there during the entire dilatation.
Pneumatic pyloric dilatation.	Pneumatic pyloric dilatation	Endoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm.

Primary Outcome Measures

Name	Time	Method
Symptoms suggestive of delayed gastric emptying	3-12 months after treatment	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	3-12 months after treatment.	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.
Delayed gastric emptying	3, 6 and 12 months after treatment.	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.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden