Study and Management of Cystic Complications in Autosomal Dominant Polycystic Kidney Disease

Active, not recruiting

• Conditions: Polycystic Kidney Diseases

• Registration Number: NCT06036992
• Lead Sponsor: University Hospital, Brest

Brief Summary

Autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. While the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. To date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. Diagnosis of these complications is often complicated, and their management has not been codified. The latest international recommendations (KDIGO) provide only low-level recommendations. For the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.

Detailed Description

Autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. While the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. To date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. Diagnosis of these complications is often complicated, and their management has not been codified. The latest international recommendations (KDIGO) provide only low-level recommendations. For the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Study Start: 2023-10-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patient with autosomal dominant polycystic kidney disease (APKD) participating in the Genkyst study

• Patient with at least one cystic complication. The cystic complications retained are the following:

  • Acute or chronic cyst-related pain requiring analgesic treatments
  • Cyst infection
  • Intracystic haemorrhage
  • Urinary lithiasis
  • Functional complaints related to the cystic mass: digestive disorders with eating disorders, undernutrition, diaphragmatic compression phenomena, portal hypertension, umbilical or linea alba hernias, ventrations
  • Need for a cystic reduction procedure: puncture, marsupialization, open surgery (including preparation for grafting)

Exclusion Criteria

• Patients who have expressed their opposition to taking part in the study
• Patient under legal protection (guardianship, curatorship, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To improve knowledge of the epidemiology of cystic complications within the Genkyst network	12 months	number of cases of cystic complications per year per complication

Secondary Outcome Measures

Name	Time	Method
Creation of a specific multidisciplinary consultation meeting	12 months	Meetings and exchanges between different health professionals: interventional radiologists, surgeons, infectiologists, hepatologists, pain specialists and nephrologists to discuss the best possible management for patients with complex cystic complications.
Creation of an image bank	12 months	consulting images to recalculate and improve diagnostic scores
Creation of a group of control patients	12 months	the change from baseline in quality of life scores at 1 year.

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France