Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy
Study Details
Study Description
Brief Summary
This is a feasibility study to assess recruitment for a randomised control trial comparing prophylactic pyloric ballon dilatation versus control group (no intervention) in Ivor-Lewis Oesophagectomy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Background Preoperative endoscopic pyloric balloon dilatation with 20 mm has been shown to decrease incidence of DGE (only 18.3 % of the intervention group developed DGE compared to 37.5% in the non-intervention group). (Hadzijusufovic et al., 2019). This however was a cohort study, and the main issue was that the intervention group had 115 patients whilst the non-dilatation group had 24 patients (tumour could not be passed with the scope). There aren't currently any published randomised control trials that looked at intra-operative endoscopic pyloric dilatation and how this relates to incidence of DGE.
Study Design Randomised controlled trial (FEASIBILITY STUDY)
Study Participants Patients undergoing Ivor Lewis Oeosphagectomy
Eligibility Criteria
Inclusion Criteria:
•All patients over the age of 18 undergoing Ivor Lewis oesophagectomy in Derriford.
Exclusion Criteria:
-
Patient declined to participate.
-
Impassable stricture at endoscopy.
-
Patient is unable to give consent.
Planned Sample Size 24- 32 patients
Follow-up Duration 3 months
Planned Study Period 1 year
Primary Objectives To measure
-
Number of patients approached
-
Number of patients who agreed to be randomised
-
Number of patients successfully randomised
-
Number of patients who drop out
-
Successful measurement of outcome measures
Secondary Objective
-
Blinding of the research team
-
Completion of questionnaire by patients to assess the ease of randomisation and their opinion about the consent process.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prophylactic pyloric balloon dilatation OGD and dilatation |
Device: 20 mm CRE balloon
Endoscopic balloon that is used to dilate pylorus
|
| Placebo Comparator: No endoscopic intervention OGD but no dilatation |
Diagnostic Test: OGD
OGD (No dilatation)
|
Outcome Measures
Primary Outcome Measures
- Rate of delayed gastric emptying [less than 14 days post op]
Chest X-ray and Nasogastric tube output
Secondary Outcome Measures
- Rate of anastomotic leak [less than 14 days post op]
If clinical indication diagnosis will be with CT
- Rate of pneumonia [less than 14 days post op]
If clinically indicated by CXR or CT
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients over the age of 18 undergoing Ivor Lewis oesophagectomy in Derriford.
Exclusion Criteria
-
Patient declined to participate.
-
Impassable stricture at endoscopy.
-
Patient is unable to give consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital Plymouth NHS Trust
Investigators
- Study Chair: Christopher Rollinson, University Hospital Plymouth NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21/SUR/574