Postprocedural Delayed Gastric EmptyingNCT05085951
Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy
A study testing 20 mm CRE balloon and OGD in people with Postprocedural Delayed Gastric Emptying, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postprocedural Delayed Gastric Emptying
- What is being tested?
- 20 mm CRE balloon and OGD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over the age of 18 undergoing Ivor Lewis oesophagectomy in Derriford.
Who cannot join
- Patient declined to participate.
- Impassable stricture at endoscopy.
- Patient is unable to give consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Plymouth NHS Trust
Plymouth, Devon, PL6 8DH
About this study
Official title: 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
Read the 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.
- Conditions
- Postprocedural Delayed Gastric Emptying
- Being tested
- 20 mm CRE balloon, OGD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mm CRE balloonDevice
Endoscopic balloon that is used to dilate pylorus
OGDDiagnostic test
OGD (No dilatation)
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic pyloric balloon dilatation | Experimental | OGD and dilatation Receives: Device: 20 mm CRE balloon |
| No endoscopic intervention | Placebo comparator | OGD but no dilatation Receives: Diagnostic Test: OGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of delayed gastric emptying
Chest X-ray and Nasogastric tube output
Measured: less than 14 days post op
Secondary outcomes (2)
Rate of anastomotic leak
If clinical indication diagnosis will be with CT
Measured: less than 14 days post op
Rate of pneumonia
If clinically indicated by CXR or CT
Measured: less than 14 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start9 Dec 2021
- Primary completion31 Aug 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprocedural Delayed Gastric EmptyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Rollinson, Study chair, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085951
- Sponsor's protocol ID
- 21/SUR/574
- Status last verified
- Nov 2023
- First submitted
- 7 Oct 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial (Feasibility Study) of Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy to Prevent Delayed Gastric Emptying
- ClinicalTrials.gov ID
- NCT05085951
- Acronym / sponsor ID
- 21/SUR/574
- Conditions
- Postprocedural Delayed Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic pyloric balloon dilatation | Experimental | Device: 20 mm CRE balloonOGD and dilatation |
| No endoscopic intervention | Placebo comparator | Diagnostic Test: OGDOGD but no dilatation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over the age of 18 undergoing Ivor Lewis oesophagectomy in Derriford.
Key exclusion criteria (3 listed)
- Patient declined to participate.
- Impassable stricture at endoscopy.
- Patient is unable to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 mm CRE balloonEndoscopic balloon that is used to dilate pylorus | Device | Prophylactic pyloric balloon dilatation |
| OGDOGD (No dilatation) | Diagnostic test | No endoscopic intervention |
Primary outcome
Rate of delayed gastric emptying
Time frame: less than 14 days post op
Chest X-ray and Nasogastric tube output
2 secondary outcomes
Rate of anastomotic leak
Time frame: less than 14 days post op
Rate of pneumonia
Time frame: less than 14 days post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Rollinson study chair
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 mm CRE balloon and OGD in people with Postprocedural Delayed Gastric Emptying, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of delayed gastric emptying (time frame: less than 14 days post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.