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

Pylorus Dysfunction After Esophagectomy. Effect of Pneumatic Dilatation.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02086461

Enrollment

Registered

2014-03-13

Start date

2014-05-31

Completion date

2020-12-31

Last updated

2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Gastric Emptying, Esophagectomy, No Signs of Cancer Recurrence

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.

Interventions

DEVICEPneumatic pyloric dilatation

OTHER15 mm pyloric balloon dilatation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026