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

January 2, 2019 updated by: Lars Lundell, Karolinska University Hospital

Pylorus Dysfunction After Esophagectomy. Effect of Pneumatic Dilatation.

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: 15 mm Pyloric balloon dilatation.
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
ACTIVE_COMPARATOR: Pneumatic pyloric dilatation.
Endoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm.
Device: Pneumatic pyloric dilatation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms suggestive of delayed gastric emptying
Time Frame: 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.
3-12 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 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.
3-12 months after treatment.
Delayed gastric emptying
Time Frame: 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.
3, 6 and 12 months after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Sahlgrenska University Hospital, Sweden
University Hospital, Linkoeping
Lund University Hospital
Region Örebro County
Uppsala University Hospital

Investigators

  • Principal Investigator: Jon Tsai, ass professor, Karolinska University Hospital, Gastrocentrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (ESTIMATE)

March 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/896-31/4 (OTHER: Swedish Ethic Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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