Effectiveness of Drainage by PCN vs. JJ in Patients With Symptoms of Obstructive Kidney Disease Caused by Urolithiasis

NCT04594161 | Completed

• 2 other identifiers: METC 2020_057NL70822.058.19
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effectiveness of percutaneous nephrostomy catheter placement versus retrograde double J catheter placement in patients with symptoms of obstructive kidney disease (with either infection and/or pain and/or kidney function deterioration) caused by urolithiasis.

Conditions

Urolithiasis; Urologic Diseases; Urinary Calculi; Urinary Obstruction; Urinary Stone; Ureteric Obstruction; Calculus Ureteral; Stone Ureter; Stone;Renal; Stone, Kidney; Stone, Urinary; Obstruction Ureter; Obstruction; Ureter Calculi; Ureter Obstruction; Kidney Diseases; Kidney Calculi; Kidney Failure, Acute; Kidney Dysfunction; Kidney Insufficiency; Pyelonephritis; Pyelonephritis Acute; Pyelonephritis Obstructive; Pyelonephritis; Calculus; Pyelonephritis; Obstruction; Pyelonephrosis; Hydronephrosis; Hydronephrosis; Infection; Hydronephrosis, Infected; Hydronephrosis; Obstruction, Ureter; Hydronephrosis; Obstruction, Renal Calculus; Hydronephrosis, Secondary; Renal Pelvis; Obstruction

Keywords

Urolithiasis; Urologic Diseases; Urinary Calculi; Urinary Obstruction; Urinary Stone; Nephrostomy; Complications; Catheter Complications; double j catheter; JJ catheter; urinary stent; percutaneous nephrostomy; stent

Outcome Measures

Primary Outcomes (4)

• time (hours) to clinical recovery regarding infection

  Unit is hours (0-∞), higher scores mean a worse outcome. Clinical recovery is defined as reaching one or more of the following criteria (all criteria are added seperately) \- If indication for drainage is infection clinical recovery is defined as: improvement of infection, indicated by a decrease of WBC (unit: mm3) in two executive laboratory results and at least below 15.000 mm3.

  3 months

• time (hours) to clinical recovery regarding infection

  Unit is hours (0-∞), higher scores mean a worse outcome. Clinical recovery is defined as reaching one or more of the following criteria (all criteria are added seperately) \- If indication for drainage is infection clinical recovery is defined as: improvement of infection, indicated by a body temperatur between 36.0-38.5 °Celsius. and/or * If indication for drainage is untreatable pain: Numeric rating score (NRS) considering pain resulting from a renal colic is improved and \< 3 points and/or * If indication for drainage is deterioration of kidney function: improvement of creatinine/ Glomerular Filtration Rate (GFR) in two executive laboratory results

  3 months

• time (hours) to clinical recovery regarding pain

  Unit is hours (0-∞), higher scores mean a worse outcome. Clinical recovery is defined as reaching one or more of the following criteria (all criteria are added seperately) If indication for drainage is untreatable pain clinical recover is defined as: Numeric Rating Score (NRS) considering pain resulting from a renal colic is improved and \< 3 points (higher scores mean greater level of pain).

  3 months

• time (in hours) to clinical recovery regarding kidney function

  Unit is hours (0-∞), higher scores mean a worse outcome. Clinical recovery is defined as reaching one or more of the following criteria (all criteria are added seperately) If indication for drainage is deterioration of kidney function: improvement of creatinine (μmol/L) and/or Glomerular Filtration Rate (ml/min/1.73 m2) in two executive laboratory results.

  3 months

Secondary Outcomes (7)

• patient reported outcome measures (PROMS) quality of life

  3 months

• patient reported outcome measures (PROMS) pain score

  3 months

• patient reported outcome measures (PROMS) satisfaction

  3 months

• patient reported outcome measures (PROMS) catheter related problems

  3 months

• patient reported outcome measures (PROMS) cost and productivity

  3 months

Study Arms (2)

Percutaneous Nephrostomy

ACTIVE COMPARATOR

drainage of the kidney by means of a percutaneous Nephrostomy

Device: Percutaneous Nephrostomy

Double J catheter

ACTIVE COMPARATOR

drainage of the kidney by means of a double J catheter

Device: Double J catheter

Interventions

Percutaneous Nephrostomy DEVICE

A Percutaneous Nephrostomy will be placed in patients with obstructive urolithiasis

Also known as: PCN, Nephrostomies, Percutaneous, Percutaneous Nephrostomies, Nephrostomy

Percutaneous Nephrostomy

Double J catheter DEVICE

A Double J catheter will be placed in patients with obstructive urolithiasis

Also known as: stent, JJ, internal stent, JJ catheter, urinary stent, internal urinary stent, ureteral stent, internal ureteral stent, internal ureteric stent, ureteric stent, ureteral stents, internal ureteral stents, internal ureteric stents, ureteric stents, double j ureteral catheter, double-j catheter, internalized double-j catheter

Double J catheter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- In order to be considered eligible to participate in this study, a subject must meet all of the following criteria:
• Male/female \>18 year
• Symptoms and/or laboratory results indicating obstructive kidney disease with or without infection.
• A kidney or ureteral stone is present on ultrasound or CT (max 3 months old prior to presentation)
• Both drainage techniques are feasible and safe in opinion of the treating physician (from logistics point of view and in the best interest of the patient).
• Willing and able to comply with filling in questionnaires and follow-up regiment

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Analphabetic or not mastering the Dutch language
• Pregnancy
• Usage of anticoagulation agents other than acetylsalicylic acid.
• Contraindication for either technique looking at history and anatomy (e.g. kidney transplant, pouch, Bricker deviation, urethral or ureteral stenosis)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Alrijne Hospital: collaborator

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Links

• official dutch website

MeSH Terms

Conditions

Urolithiasis; Urologic Diseases; Urinary Calculi; Ureteral Obstruction; Ureterolithiasis; Nephrolithiasis; Kidney Calculi; Bites and Stings; Kidney Diseases; Acute Kidney Injury; Renal Insufficiency; Pyelonephritis; Calculi; Hydronephrosis; Infections; Pyonephrosis; Neoplasm Metastasis

Interventions

Nephrostomy, Percutaneous; Nephrotomy; Stents

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureteral Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Nephritis, Interstitial; Nephritis; Pyelitis; Neoplastic Processes; Neoplasms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Ostomy; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Urinary Diversion; Prostheses and Implants; Equipment and Supplies

Study Officials

• Ad Hendrikx, dr.

  no affiliation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is possible because stent is visible to patient and physician
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor H.P. Beerlage

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: October 20, 2020
• Study Start: July 15, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)