Pylorus Dysfunction After Esophagectomy and Gastric Tube Reconstruction. Effect of Pneumatic Pylorus Dilatation During Hospital Stay, Surgical Complications During in Hospital Stay
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 3, 2019
January 1, 2019
6.6 years
March 11, 2014
January 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3-12 months after treatment
Secondary Outcomes (2)
Quality of Life
3-12 months after treatment.
Delayed gastric emptying
3, 6 and 12 months after treatment.
Study Arms (2)
15 mm Pyloric balloon dilatation.
SHAM COMPARATORDuring fluoroscopic control the pneumatic balloon is positioned of the pyloric sphincter and maintained there during the entire dilatation.
Pneumatic pyloric dilatation.
ACTIVE COMPARATOREndoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm.
Interventions
Eligibility Criteria
You may qualify if:
- Previous esophagectomy and gastric tube reconstruction.
- Symptoms suggestive of delayed gastric emptying.
- signed informed consent
You may not qualify if:
- Signs of recurrent cancer disease
- no symptoms suggestive of delayed gastric emptying.
- unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Lund University Hospitalcollaborator
- Sahlgrenska University Hospitalcollaborator
- Region Örebro Countycollaborator
- Uppsala University Hospitalcollaborator
- University Hospital, Linkoepingcollaborator
Study Sites (1)
Karolinska University Hospital
Stockholm, 14186, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Tsai, ass professor
Karolinska University Hospital, Gastrocentrum
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 11, 2014
First Posted
March 13, 2014
Study Start
May 1, 2014
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
January 3, 2019
Record last verified: 2019-01