Modified Mini-PCNL Versus Standard PCNL for Complex Kidney Stones (MIMIC-PCNL)
Modified Mini Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy for the Treatment of Complex Renal Calculi: A Multicenter Randomized Controlled Trial
Kidney stones that are large or complex are often treated with percutaneous nephrolithotomy, also called PCNL. Standard PCNL uses a larger access tract and is effective for removing complex kidney stones, but it may be associated with more bleeding, pain, and recovery burden. Modified mini-PCNL uses a smaller access tract and may reduce surgical trauma while maintaining a similar stone clearance rate.
This multicenter randomized trial will compare modified mini-PCNL using a 20 Fr access sheath with standard PCNL using a 24 Fr access sheath in adults with complex renal stones. About 1,380 participants from 8 urology centers will be randomly assigned to receive one of the two procedures. The main purpose of the study is to determine whether modified mini-PCNL is not worse than standard PCNL in achieving stone-free status shortly after surgery. Stone-free status will be assessed by low-dose noncontrast CT within 72 hours after surgery. The study will also compare stone-free status at 3 months, complications, operation time, length of hospital stay, need for additional procedures, and quality of life.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yongda Liu, Doctor
- 電話番号：+020-83062923
- メール：13719007083@163.com
研究場所
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510120
- 募集
- The First Affiliated Hospital of Guangzhou Medical University
-
コンタクト：
- Yongda Liu
- 電話番号：+020-83062923
- メール：13719007083@163.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged ≥18 years.
- Serum creatinine ≤133 μmol/L.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- S.T.O.N.E. score ≥8.
- Complex renal stones confirmed by noncontrast computed tomography, including stone surface area >1500 mm², multiple calyceal stones, partial or complete staghorn calculi, or complex anatomical conditions.
- Patients who provide written informed consent and agree to undergo either modified mini-percutaneous nephrolithotomy or standard percutaneous nephrolithotomy.
Exclusion Criteria:
- Solitary kidney.
- Morbid obesity (body mass index ≥35 kg/m²).
- Previous renal transplantation or urinary diversion.
- Congenital abnormalities of the urinary tract.
- Pregnancy.
- Uncorrected coagulopathy.
- Active urinary tract infection.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Modified Mini-PCNL
Participants randomized to this arm will undergo 20 Fr modified mini percutaneous nephrolithotomy using the F17 Hawk nephroscope for the treatment of complex renal stones.
|
Modified mini percutaneous nephrolithotomy performed with a 20 Fr access sheath and F17 Hawk nephroscope.
Stone fragmentation may be performed using pneumatic lithotripsy, Ho:YAG laser, or thulium fiber laser according to the standardized surgical protocol.
他の名前：
|
|
アクティブコンパレータ：Standard PCNL
Participants randomized to this arm will undergo 24 Fr standard percutaneous nephrolithotomy using the F20.8 Wolf nephroscope for the treatment of complex renal stones.
|
Standard percutaneous nephrolithotomy performed with a 24 Fr access sheath and F20.8 Wolf nephroscope.
Stone fragmentation may be performed using pneumatic lithotripsy, Ho:YAG laser, or thulium fiber laser according to the standardized surgical protocol.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Immediate Stone-Free Rate
時間枠：Within 72 hours after surgery
|
Proportion of participants who achieve stone-free status after surgery.
Stone-free status is defined as no residual stone visualized under endoscopy and no residual stone fragments, or residual fragments ≤2 mm, on low-dose noncontrast CT with 2-mm slice thickness.
|
Within 72 hours after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Stone-Free Rate at 3 Months
時間枠：3 months after surgery
|
Proportion of participants who achieve stone-free status at 3-month follow-up according to low-dose noncontrast CT.
|
3 months after surgery
|
|
Length of Hospital Stay
時間枠：From surgery to hospital discharge, assessed up to 30 days after surgery
|
Number of days from the day of surgery to the day of hospital discharge, rounded to the nearest whole day.
|
From surgery to hospital discharge, assessed up to 30 days after surgery
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ES-2025-285-02
- GMUCR2025-01006 (その他の助成金/資金番号：Guangzhou Medical University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。