Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy

Randomised Controlled Trial (Feasibility Study) of Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy to Prevent Delayed Gastric Emptying

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

Study Overview

• Status: Completed
• Conditions: Postprocedural Delayed Gastric Emptying
• Intervention / Treatment: Device: 20 mm CRE balloon; Diagnostic test: OGD

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • University Hospitals Plymouth NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of delayed gastric emptying	Chest X-ray and Nasogastric tube output	less than 14 days post op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of anastomotic leak	If clinical indication diagnosis will be with CT	less than 14 days post op
Rate of pneumonia	If clinically indicated by CXR or CT	less than 14 days post op

Collaborators and Investigators

• Sponsor: University Hospital Plymouth NHS Trust
• Investigators: Study Chair: Christopher Rollinson, University Hospitals Plymouth NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: 21/SUR/574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No