CancerPhase 2GASTROXYNCT04250805
Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
A Phase 2 study testing Lidocaine and Ropivacaine in people with Cancer and Feeding Disorders, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Gastrostomy is an intra-gastric nutritional enteral device that could be put in place by percutaneous technique under radiological guidance: allowing local anesthesia. However, there is no clear recommendation about local analgesia during this exam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Feeding Disorders
- What is being tested?
- Lidocaine and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Oct 2020to 23 Jan 2024
- Phase
- Phase 2
- 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
- Major patient;
- Having an indication for placement of PRG (percutaneous radiological gastrostomy);
- Patient hospitalized for a minimum of 24 hours post gastrostomy;
- Non-inclusion criteria :
- Pregnant or lactating woman;
- Legal incapacity or limited legal capacity. Medical or psychological conditions which do not allow the subject to understand the study and sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9);
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- Not knowing how to read and / or write French;
- Allergy and / or known hypersensitivity to lidocaine and / or ropivacaine or to other local anesthetics with amide bond or to one of the excipients;
- Recurrent porphyrias (genetic, hereditary diseases affecting the production of hemoglobin);
- Patient on beta blockers during the installation of PRG (Percutaneous Radiological Gastrostomy);
- Indication of gastrostomy button placement.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
About this study
Gastrostomy is an intra-gastric nutritional enteral device that could be put in place by percutaneous technique under radiological guidance: allowing local anesthesia. However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action. The association of these two drugs could enhance the analgesia post procedure. The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.
Read the detailed description
Gastrostomy is an intra-gastric nutritional enteral device, allowing the nutritional support for patients presenting oral feeding disorders. Gastrostomy could be put in place by different manners:
- Chirurgical technique or endoscopy: with general anesthesia;
- Percutaneous technique under radiological guidance: allowing local anesthesia. This last one is better tolerated by weak patients, and involves less complication.
However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action.
The association of these two drugs could enhance the analgesia post procedure. Indeed, pain felt during the twenty four hours post procedure seems to be the most frequent adverse effect reported by patients.
Pain could decrease significantly when Ropivacaine is added to the reference Xylocaine. Ropivacaine had already proved its efficacy in association with other antalgics.
The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.
- Conditions
- Cancer, Feeding Disorders
- Being tested
- Lidocaine, Ropivacaine
- Keywords
- Cancer, Gastrostomy, Percutaneous technique, Radiological guidance, Lidocaine, Ropivacaine, Pain
- Medical subject headings
- Neoplasms, Feeding and Eating Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.
RopivacaineDrug
Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance Receives: Drug: Lidocaine |
| Lidocaine and Ropivacaine | Experimental | Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance Receives: Drug: Lidocaine; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Pain
Two points diminution for maximal pain felt during a twenty four hours after percutaneous gastrostomy under radiological guidance. It will be measured with a visual analogue scale starting at zero for no pain and ending at ten for maximal pain felt.
Measured: 24 hours
Secondary outcomes (3)
Level of Anxiety and Depression
Hospital Anxiety and Depression scores will be reported and analysed for each patient. This scale is an instrument for detecting anxiety and depressive disorders. It has 14 listed items from 0 to 3. Seven questions relate to anxiety (total A) and seven others relate to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21). To detect anxious and depressive symptoms, the following interpretation can be offered for each of the scores (A and D):
- 7 or less: absence of symptoms;
- 8 to 10: doubtful symptomatology;
- 11 and more: certain symptomatology.
Measured: 10 days
Level of quality of life
Brief Pain Inventory scores will be reported to evaluate the level of the patients' quality of life. For each question, score is comprised between 0 and 10, with 0 meaning no pain or no resounding on life activity, and 10 meaning the worst pain ever, and the worst resounding on life activity.
Measured: 10 days
Level of satisfaction
Patients' satisfaction about their analgesic care will be reported with a visual analogue scale starting at zero meaning no satisfaction, and ending at ten meaning the highest satisfaction possible.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start27 Oct 2020
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Why it stopped: Difficulties in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Guillaume Etievent, MD, Principal investigator, Institut de Cancérologie Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250805
- Sponsor's protocol ID
- 2019-1201
- Other IDs
- 2019-004835-22, 2019
- Acronym
- GASTROXY
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2020
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
- ClinicalTrials.gov ID
- NCT04250805
- Acronym / sponsor ID
- GASTROXY / 2019-1201
- Conditions
- Cancer, Feeding Disorders
- Keywords
- Cancer, Gastrostomy, Percutaneous technique, Radiological guidance, Lidocaine, Ropivacaine, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting patients
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 31 Jan 2020 (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.
Gastrostomy is an intra-gastric nutritional enteral device that could be put in place by percutaneous technique under radiological guidance: allowing local anesthesia. However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action. The association of these two drugs could enhance the analgesia post procedure. The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.
Detailed description
Gastrostomy is an intra-gastric nutritional enteral device, allowing the nutritional support for patients presenting oral feeding disorders. Gastrostomy could be put in place by different manners:
- Chirurgical technique or endoscopy: with general anesthesia;
- Percutaneous technique under radiological guidance: allowing local anesthesia. This last one is better tolerated by weak patients, and involves less complication.
However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action.
The association of these two drugs could enhance the analgesia post procedure. Indeed, pain felt during the twenty four hours post procedure seems to be the most frequent adverse effect reported by patients.
Pain could decrease significantly when Ropivacaine is added to the reference Xylocaine. Ropivacaine had already proved its efficacy in association with other antalgics.
The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: LidocainePatients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance |
| Lidocaine and Ropivacaine | Experimental | Drug: Lidocaine, Drug: RopivacainePatients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Major patient;
- Having an indication for placement of PRG (percutaneous radiological gastrostomy);
- Patient hospitalized for a minimum of 24 hours post gastrostomy;
- Pregnant or lactating woman;
- Legal incapacity or limited legal capacity. Medical or psychological conditions which do not allow the subject to understand the study and sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9);
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LidocainePatients will receive Lidocaine during percutaneous gastrostomy under radiological guidance. | Drug | Lidocaine, Lidocaine and Ropivacaine |
| RopivacainePatients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance. | Drug | Lidocaine and Ropivacaine |
Primary outcome
Level of Pain
Time frame: 24 hours
Two points diminution for maximal pain felt during a twenty four hours after percutaneous gastrostomy under radiological guidance. It will be measured with a visual analogue scale starting at zero for no pain and ending at ten for maximal pain felt.
3 secondary outcomes
Level of Anxiety and Depression
Time frame: 10 days
Level of quality of life
Time frame: 10 days
Level of satisfaction
Time frame: 10 days
Results and safety
The study was stopped early (reason given: Difficulties in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- 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.
Guillaume Etievent, MD principal investigator
Institut de Cancérologie Lucien Neuwirth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine and Ropivacaine in people with Cancer and Feeding Disorders, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
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 11 inclusion and 0 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: stopped early, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting patients). Results are not available in the source record.
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?
Level of Pain (time frame: 24 hours). 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 31 Jan 2024.