Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05618392

Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gastrostomy Complications Gastrostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandrine Beauchard

Valence, 26400, France

Location status: Recruiting

Location contact

sandrine Beauchard, MD

CONTACT

[email protected]

+33475818870

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Needing a radiologic gastrostomy under local anesthesia
  • Age ≥ 18 years old
  • Read, write and understand the French language

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. abdominal pain

    Time frame: 7 days

    numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume BUIRET, MD

CONTACT

[email protected]

+33475818870

Mathilde FINOT, MD

CONTACT

[email protected]

+33475818870

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valence

Other

Registry information

Acronym: DOULEURGPR

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 16, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.