Gastrostomy ComplicationsDOULEURGPRNCT05618392
Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors
An observational study of Gastrostomy Complications and Gastrostomy, run by Centre Hospitalier de Valence at 1 site in France.
Trial summary
A 12 months mono-center, descriptive study, to evaluate pain and predictive factors Following placement of percutaneous Radiologic gastrostomy (PRG). The primary objective is to evaluate the abdominal pain associated with percutaneous radiologic gastrostomy (PRG) placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrostomy Complications, Gastrostomy
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2022to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: patients needing a Percutaneous radiologic Gastrostomy under local anesthesia
Who may be able to join
- Needing a radiologic gastrostomy under local anesthesia
- Age ≥ 18 years old
- Read, write and understand the French language
Who cannot join
- Patient under guardianship, deprived of liberty, safeguard of justice
- Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator)
- Refusal to participate in research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Sandrine Beauchard
Valence, 26400
sandrine Beauchard, MD, +33475818870, sbeauchard@ch-valence.fr
About this study
A 12 months mono-center, descriptive study, to evaluate pain and predictive factors Following placement of percutaneous Radiologic gastrostomy (PRG).
The primary objective is to evaluate the abdominal pain associated with percutaneous radiologic gastrostomy (PRG) placement.
Read the detailed description
PRG is a pathway first of all enteral nutrition that has several advantages: local anesthesia, possible in case of esophageal stenosis, Rates of successful tube placement higher for radiologic gastrostomy than for percutaneous endoscopic Gastrostomy (PEG).
Abdominal pain following percutaneous radiologic gastrostomy (PRG) placement is a recognized complication. However, the prevalence and degree of severity of pain are poorly characterized. This pain often requires antalgic treatment.
The primary objective is to evaluate the abdominal pain from Baseline until 7 days after radiologic gastrostomy (PRG) placement.
The secondary objective is to evaluate predictive factors
- Conditions
- Gastrostomy Complications, Gastrostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| single group assignment | only one arm. Each patient complete numerical scale questionnaire (0-10) |
What is being measured
The primary outcome is the main question the study is designed to answer.
abdominal pain
numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Measured: 7 days
predictive factors
determine predictive factors of pain suspected in advance:
- Fasting anterior stomach wall depth estimated during the ultrasound survey(mm)
- Gastric topography determined under X-ray (subcostal / partially retrohepatic)
- Topography of the anchors: large tuberosity / antrum
- Distance of anchors from each other (mm)
- Depth of the anchors (mm)
- Skin depression of anchors: (with depression, without depression)
- Intraparietal length of the gastrostomy tube (mm)
Measured: DAY 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start9 Dec 2022
- Primary completion9 Dec 2025
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrostomy ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valence
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618392
- Sponsor's protocol ID
- RIPH-CHV-11
- Acronym
- DOULEURGPR
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors
- ClinicalTrials.gov ID
- NCT05618392
- Acronym / sponsor ID
- DOULEURGPR / RIPH-CHV-11
- Conditions
- Gastrostomy Complications, Gastrostomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ValenceUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 16 Nov 2022 (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.
A 12 months mono-center, descriptive study, to evaluate pain and predictive factors Following placement of percutaneous Radiologic gastrostomy (PRG).
The primary objective is to evaluate the abdominal pain associated with percutaneous radiologic gastrostomy (PRG) placement.
Detailed description
PRG is a pathway first of all enteral nutrition that has several advantages: local anesthesia, possible in case of esophageal stenosis, Rates of successful tube placement higher for radiologic gastrostomy than for percutaneous endoscopic Gastrostomy (PEG).
Abdominal pain following percutaneous radiologic gastrostomy (PRG) placement is a recognized complication. However, the prevalence and degree of severity of pain are poorly characterized. This pain often requires antalgic treatment.
The primary objective is to evaluate the abdominal pain from Baseline until 7 days after radiologic gastrostomy (PRG) placement.
The secondary objective is to evaluate predictive factors
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group assignment | – | –only one arm. Each patient complete numerical scale questionnaire (0-10) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients needing a Percutaneous radiologic Gastrostomy under local anesthesia
Key inclusion criteria (3 listed)
- Needing a radiologic gastrostomy under local anesthesia
- Age ≥ 18 years old
- Read, write and understand the French language
Key exclusion criteria (3 listed)
- Patient under guardianship, deprived of liberty, safeguard of justice
- Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator)
- Refusal to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
abdominal pain
Time frame: 7 days
numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
predictive factors
Time frame: DAY 1
determine predictive factors of pain suspected in advance: * Fasting anterior stomach wall depth estimated during the ultrasound survey(mm) * Gastric topography determined under X-ray (subcostal / partially retrohepatic) * Topography of the anchors: large tuberosity / antrum * Distance of anchors from each other (mm) * Depth of the anchors (mm) * Skin depression of anchors: (with depression, without depression) * Intraparietal length of the gastrostomy tube (mm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrostomy Complications and Gastrostomy, run by Centre Hospitalier de Valence at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde FINOT, MD (+33475818870, mfinot@ch-valence.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abdominal pain (time frame: 7 days). The study lists 2 primary outcomes in all. 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 Mar 2026.