Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05618392
Other study ID # 00005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 9, 2022
Est. completion date January 1, 2026

Study information

Verified date December 2023
Source Centre Hospitalier de Valence
Contact Mathilde FINOT, MD
Phone +33475818870
Email mfinot@ch-valence.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 1, 2026
Est. primary completion date December 9, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Sandrine Beauchard Valence

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier de Valence

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary abdominal pain numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." 7 days
Primary 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)
DAY 1
See also
  Status Clinical Trial Phase
Recruiting NCT03959878 - Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes. N/A
Active, not recruiting NCT04566367 - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer N/A
Recruiting NCT04110613 - RCT: Early Feeding After PEG Placement N/A
Completed NCT03319576 - Early Feeding Following Percutaneous Gastrostomy Tube Placement N/A
Completed NCT03575754 - A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique N/A
Enrolling by invitation NCT06129877 - CHAMP App Feeding Difficulties Repository
Completed NCT04183296 - The Effect of Total Intravenous Anesthesia and Volatile Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Laparoscopic or Robotic Assisted Gastrectomy N/A
Recruiting NCT02909205 - a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised N/A
Recruiting NCT04636099 - Gastrointestinal Surgery Study Group 2001 N/A
Not yet recruiting NCT05955534 - Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy N/A
Completed NCT02869321 - Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy Phase 4
Recruiting NCT05205343 - Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
Recruiting NCT03874871 - Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients
Completed NCT03252509 - Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors N/A
Completed NCT04804631 - Tube Feeding in Children Having a Bone Marrow Transplant
Terminated NCT01825564 - Comparison of RightSpot pH Indicator & RightLevel pH Detector With X-Ray Verification for FT or G-Tube Placement N/A
Completed NCT04919577 - Predictive Factors for Roux Stasis Syndrome
Completed NCT04151030 - Endoscopic Direct-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure N/A
Completed NCT05994079 - Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy N/A
Recruiting NCT04808206 - A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy