NCT05085951

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 9, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

October 7, 2021

Last Update Submit

November 17, 2023

Conditions

Postprocedural Delayed Gastric Emptying

Outcome Measures

Primary Outcomes (1)

  • Rate of delayed gastric emptying

    Chest X-ray and Nasogastric tube output

    less than 14 days post op

Secondary Outcomes (2)

  • Rate of anastomotic leak

    less than 14 days post op

  • Rate of pneumonia

    less than 14 days post op

Study Arms (2)

Prophylactic pyloric balloon dilatation

EXPERIMENTAL

OGD and dilatation

Device: 20 mm CRE balloon

No endoscopic intervention

PLACEBO COMPARATOR

OGD but no dilatation

Diagnostic Test: OGD

Interventions

20 mm CRE balloonDEVICE

Endoscopic balloon that is used to dilate pylorus

Prophylactic pyloric balloon dilatation
OGDDIAGNOSTIC_TEST

OGD (No dilatation)

No endoscopic intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients over the age of 18 undergoing Ivor Lewis oesophagectomy in Derriford.

You may not qualify if:

  • Patient declined to participate.
  • Impassable stricture at endoscopy.
  • Patient is unable to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Study Officials

  • Christopher Rollinson

    University Hospitals Plymouth NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 20, 2021

Study Start

December 9, 2021

Primary Completion

August 31, 2022

Study Completion

June 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)