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

NCT ID: NCT02086461

Last Updated: 2019-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Esophagectomy No Signs of Cancer Recurrence Delayed Gastric Emptying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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15 mm Pyloric balloon dilatation.

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

Group Type SHAM_COMPARATOR

15 mm pyloric balloon dilatation

Intervention Type OTHER

Pneumatic pyloric dilatation.

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

Group Type ACTIVE_COMPARATOR

Pneumatic pyloric dilatation

Intervention Type DEVICE

Interventions

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Pneumatic pyloric dilatation

Intervention Type DEVICE

15 mm pyloric balloon dilatation

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University Hospital

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Lundell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jon Tsai, ass professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital, Gastrocentrum

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2013/896-31/4

Identifier Type: OTHER

Identifier Source: secondary_id

2013/896-31/4

Identifier Type: -

Identifier Source: org_study_id

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