Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy
Primary Purpose
Postprocedural Delayed Gastric Emptying
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
20 mm CRE balloon
OGD
Sponsored by
About this trial
This is an interventional other trial for Postprocedural Delayed Gastric Emptying
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.
Sites / Locations
- University Hospitals Plymouth NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Prophylactic pyloric balloon dilatation
No endoscopic intervention
Arm Description
OGD and dilatation
OGD but no dilatation
Outcomes
Primary Outcome Measures
Rate of delayed gastric emptying
Chest X-ray and Nasogastric tube output
Secondary Outcome Measures
Rate of anastomotic leak
If clinical indication diagnosis will be with CT
Rate of pneumonia
If clinically indicated by CXR or CT
Full Information
NCT ID
NCT05085951
First Posted
October 7, 2021
Last Updated
May 2, 2023
Sponsor
University Hospital Plymouth NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT05085951
Brief Title
Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy
Official Title
Randomised Controlled Trial (Feasibility Study) of Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy to Prevent Delayed Gastric Emptying
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Plymouth NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
Detailed Description
The Ivor Lewis gastro-oesophagectomy is a complex operation that is performed to treat cancer of the oesophagus (food pipe) whereby most of the oesophagus and upper stomach are removed and the remaining stomach is brought into the chest and joined to the remaining oesophagus. In order to reduce the burden of complications of the procedure, research has been conducted in search of methods to improve the procedure and outcomes after the operation. Delayed gastric emptying (how quickly food empties out of your stomach into your small bowel) is a common problem after this operation (20% of patients). The situation can lead to a feeling of being full up, loss of appetite and nausea. Rarely, in severe cases patients may vomit or food going into lung causing a chest infection or develop a leak from the operative joint which can prolong hospital stay by an average of 5 days. Treatment currently is uncertain, as is the scale of problem (how common it is) and there is no standard definition for delayed gastric emptying (there is no agreed standard way to describe slow emptying of food from the stomach into the small bowel by experts). There is a theory that the problem might be caused due to the outlet of the stomach (pylorus) narrowing down. Prevention of the problem is also uncertain.
In order to investigate prevention of the problem, the study will involve randomising patients during the oesophagectomy to either dilatation (stretching) of the pylorus with a balloon, or not, and completion of an abbreviated quality of life questionnaire (8 multiple choice questions).
During the oesophagectomy, all patients routinely have endoscopy (camera test of the gullet and stomach) to assess the tumour. It is during this part of the operation that you will be randomised to either the balloon group or no intervention. The questionnaire is to assess your quality of life, in terms of delayed gastric emptying, at different points after the operation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprocedural Delayed Gastric Emptying
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic pyloric balloon dilatation
Arm Type
Experimental
Arm Description
OGD and dilatation
Arm Title
No endoscopic intervention
Arm Type
Placebo Comparator
Arm Description
OGD but no dilatation
Intervention Type
Device
Intervention Name(s)
20 mm CRE balloon
Intervention Description
Endoscopic balloon that is used to dilate pylorus
Intervention Type
Diagnostic Test
Intervention Name(s)
OGD
Intervention Description
OGD (No dilatation)
Primary Outcome Measure Information:
Title
Rate of delayed gastric emptying
Description
Chest X-ray and Nasogastric tube output
Time Frame
less than 14 days post op
Secondary Outcome Measure Information:
Title
Rate of anastomotic leak
Description
If clinical indication diagnosis will be with CT
Time Frame
less than 14 days post op
Title
Rate of pneumonia
Description
If clinically indicated by CXR or CT
Time Frame
less than 14 days post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Rollinson
Organizational Affiliation
University Hospitals Plymouth NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy
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