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

Sponsor

Karolinska University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02086461

Collaborator

Lund University Hospital (Other), Sahlgrenska University Hospital, Sweden (Other), Region Örebro County (Other), Uppsala University Hospital (Other), University Hospital, Linkoeping (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophagectomy No Signs of Cancer Recurrence Delayed Gastric Emptying	Device: Pneumatic pyloric dilatation Other: 15 mm pyloric balloon dilatation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Pylorus Dysfunction After Esophagectomy. Effect of Pneumatic Dilatation.

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden	14186

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lars Lundell, Professor, Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT02086461

Other Study ID Numbers:

2013/896-31/4
2013/896-31/4

First Posted:

Mar 13, 2014

Last Update Posted:

Jan 3, 2019

Last Verified:

Jan 1, 2019

Additional relevant MeSH terms:

Gastroparesis

Recurrence

Study Results

No Results Posted as of Jan 3, 2019