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

Primary Purpose

Esophagectomy, No Signs of Cancer Recurrence, Delayed Gastric Emptying

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Pneumatic pyloric dilatation
15 mm pyloric balloon dilatation
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

15 mm Pyloric balloon dilatation.

Pneumatic pyloric dilatation.

Arm Description

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

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

Outcomes

Primary Outcome Measures

Symptoms suggestive of delayed gastric emptying
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

Quality of Life
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
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.

Full Information

First Posted
March 11, 2014
Last Updated
January 2, 2019
Sponsor
Karolinska University Hospital
Collaborators
Lund University Hospital, Sahlgrenska University Hospital, Sweden, Region Örebro County, Uppsala University Hospital, University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT02086461
Brief Title
Pylorus Dysfunction After Esophagectomy and Gastric Tube Reconstruction. Effect of Pneumatic Pylorus Dilatation During Hospital Stay, Surgical Complications During in Hospital Stay
Official Title
Pylorus Dysfunction After Esophagectomy. Effect of Pneumatic Dilatation.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Lund University Hospital, Sahlgrenska University Hospital, Sweden, Region Örebro County, Uppsala University Hospital, University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagectomy, No Signs of Cancer Recurrence, Delayed Gastric Emptying

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
15 mm Pyloric balloon dilatation.
Arm Type
Sham Comparator
Arm Description
During fluoroscopic control the pneumatic balloon is positioned of the pyloric sphincter and maintained there during the entire dilatation.
Arm Title
Pneumatic pyloric dilatation.
Arm Type
Active Comparator
Arm Description
Endoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm.
Intervention Type
Device
Intervention Name(s)
Pneumatic pyloric dilatation
Intervention Type
Other
Intervention Name(s)
15 mm pyloric balloon dilatation
Primary Outcome Measure Information:
Title
Symptoms suggestive of delayed gastric emptying
Description
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.
Time Frame
3-12 months after treatment
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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.
Time Frame
3-12 months after treatment.
Title
Delayed gastric emptying
Description
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.
Time Frame
3, 6 and 12 months after treatment.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Tsai, ass professor
Organizational Affiliation
Karolinska University Hospital, Gastrocentrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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