An interventional study of Pneumatic pyloric dilatation and 15 mm pyloric balloon dilatation in Esophagectomy, No Signs of Cancer Recurrence and Delayed Gastric Emptying, sponsored by Karolinska University Hospital. Status unknown at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2019-01-03.
Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Treatment
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.
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.
311 studies on the registry are indexed under Gastroparesis; 67 are open to participants now.
This study's planned enrollment of 40 is close to the median of 42 across 205 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →Karolinska University Hospital is the lead sponsor of 278 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
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
Endoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm.
Device: Pneumatic pyloric dilatation
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.
Time frame: 3-12 months after treatment
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.
Time frame: 3-12 months after treatment.
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.
Time frame: 3, 6 and 12 months after treatment.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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