Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05085951 |
| Other study ID # |
21/SUR/574 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 9, 2021 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
University Hospital Plymouth NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
