Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction

NCT02160652 | Unknown DMC

• 1 other identifier: 0185-14-RMC
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single center single arm prospective study, assessing the outcome of ureteral re-implantation for malignant ureteral obstruction.

Conditions

Ureteral Obstruction

Keywords

Ureteral Obstruction; HYDRONEPHROSIS; nephrostomy tube

Outcome Measures

Primary Outcomes (1)

• Ureteral patency - 6 months

  Ureteral patency at 6 months following the operation- assessed by stable or improved hydronephrosis and estimated GFR according to the CKD-EPI equation.

  6 months following the operation

Secondary Outcomes (4)

• Ureteral patency - 12 months

  12 months following the operation

• Post-operative complications

  1, 3, 6, and 12-months following the operation

• Quality of life

  1,3,6, and 12 months following the operation

• Re-intervention

  12 months following the operation

Study Arms (1)

Patients

Patients with malignant ureteral obstruction, treated with laparoscopic ureteral re-implantation, who have a life expectancy of over 6 months and are willing and able to participate in the study.

Procedure: Laparoscopic ureteral re-implantation.

Interventions

Laparoscopic ureteral re-implantation. PROCEDURE

Laparoscopic ureteral re-implantation for the treatment of malignant ureteral obstruction.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant ureteral obstruction, treated with laparoscopic ureteral re-implantation, who have a life expectancy of over 6 months and are willing and able to participate in the study.

You may qualify if:

• Adult patient, older than 18 years of age.
• Patient with malignant ureteral obstruction diagnosed by creatinine elevation with evidence of ureteral obstruction on imaging.
• Patient is scheduled for ureteral reimplantation due to extrinsic malignant ureteral obstruction.
• American Society of Anesthesiologist score ≤3, enabling the patient to undergo surgery.

You may not qualify if:

• WHO performance status 0-2
• The patient is willing and able to read, understand and sign the study specific informed consent form
• Patients who underwent urinary diversion other than percutaneous nephrostomy or retrograde ureteral stenting prior to the planned treatment.
• Patients unable to sign an informed consent for or unwilling to undergo so.
• Life expectancy of less than 6 months, as defined according to the criteria by Ishioka et al. and predicted in the presence of:
• Low serum albumin before percutaneous nephrostomy/ retrograde ureteral stenting (3 gm/dl or less).
• Low grade hydronephrosis prior to percutaneous nephrostomy/ retrograde ureteral stenting placement (grade 1 or 2) as graded by the grading system of the Society for Fetal Urology
• Malignant ascites or malignant pleural effusion.

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Conditions

Ureteral Obstruction; Hydronephrosis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases

Study Officials

• David Margel, MD, PhD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 11, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 17, 2017

Record last verified: 2017-10