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

Karolinska University Hospital

Status: Unknown

Conditions: No Signs of Cancer Recurrence; Delayed Gastric Emptying; Esophagectomy

Treatments: Other: 15 mm pyloric balloon dilatation; Device: Pneumatic pyloric dilatation

Study type: Interventional

Funder types: Other

Identifiers

NCT02086461

2013/896-31/4 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

15 mm Pyloric balloon dilatation.

Sham Comparator group

Description:

During fluoroscopic control the pneumatic balloon is positioned of the pyloric sphincter and maintained there during the entire dilatation.

Treatment:

Other: 15 mm pyloric balloon dilatation

Pneumatic pyloric dilatation.

Active Comparator group

Description:

Endoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm.

Treatment:

Device: Pneumatic pyloric dilatation