Safety and Efficacy of Ultrasound-Guided Percutaneous Nephrostomy in Oncology Patients
Obstructive uropathy is a serious complication frequently seen in cancer patients, occurring when urine flow from the kidneys is blocked by tumor compression, invasion, or benign etiologies such as radiation-induced strictures and stones. If left untreated, this blockage leads to hydronephrosis, acute kidney impairment, and interruptions in cancer therapy. When internal ureteral stenting fails or is not possible, percutaneous nephrostomy (PCN), which involves inserting a small drainage tube through the back directly into the renal collecting system, is required to decompress the kidney and preserve renal function.
Traditionally, PCN is performed under fluoroscopy, exposing patients and healthcare staff to ionizing radiation. Ultrasound guidance provides continuous real-time visualization of the renal structures while completely eliminating radiation hazards.
The primary purpose of this prospective interventional study is to evaluate the technical success, safety, and complication rates of ultrasound-guided percutaneous nephrostomy in oncology patients presenting with urinary tract obstruction.
Participants in this study undergo ultrasound-guided PCN under local anesthesia using the standard Seldinger technique to place an 8Fr pigtail drainage catheter. The study evaluates the technical success rate of the procedure, procedural and post-procedural complications (such as bleeding or sepsis), recovery of kidney function measured by changes in serum creatinine levels, and hospital length of stay.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients with known or suspected primary malignancy.
- Confirmed ureteric obstruction on diagnostic imaging (ultrasound or CT), whether due to malignant etiology (e.g., extrinsic tumor compression or direct invasion) or benign etiology (e.g., calculi, radiation-induced stricture, or iatrogenic injury).
- Clinical or biochemical evidence of acute renal impairment or symptomatic hydronephrosis necessitating urgent or elective decompression.
Exclusion Criteria:
- Patients who refuse the intervention or withdraw consent.
- Patients undergoing simultaneous retrograde or antegrade ureteric stent placement during the same procedure.
- Patients with uncorrectable coagulopathy (abnormal PT/INR or severe thrombocytopenia).
- Strict medical contraindications to percutaneous interventions.
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Ultrasound-Guided Percutaneous Nephrostomy
Participants with known or suspected primary malignancy presenting with ureteric obstruction undergo ultrasound-guided percutaneous nephrostomy (PCN) using the standard Seldinger technique. Under local anesthesia and real-time ultrasound guidance, percutaneous access to the collecting system (targeting a lower pole posterior calyx) is achieved using an 18-gauge puncture needle (or 21/22-gauge Chiba needle). A 0.035-inch or 0.038-inch J-tip guidewire is advanced into the renal pelvis, followed by serial fascial dilation and placement of an 8Fr locking pigtail nephrostomy catheter connected to external gravity drainage. |
Ultrasound-guided placement of a percutaneous nephrostomy (PCN) catheter using the standard Seldinger technique. Under local anesthesia (1% or 2% lidocaine) and continuous real-time ultrasound visualization without fluoroscopy, access to the dilated pelvicalyceal system is achieved via posterolateral puncture targeting a lower pole posterior calyx using an 18-gauge needle (or 21/22-gauge Chiba needle). A 0.035-inch or 0.038-inch J-tip guidewire is advanced and coiled within the renal pelvis. The tract is serially dilated over the guidewire using sequential fascial dilators, followed by insertion of an 8Fr locking pigtail nephrostomy catheter into the renal collecting system. Proper intrapelvic positioning is confirmed sonographically and via free drainage of urine. The catheter is locked, sutured to the skin with non-absorbable sutures, dressed sterilely, and connected to an external gravity drainage bag. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Technical Success Rate of Ultrasound-Guided Percutaneous Nephrostomy
時間枠：24 hours post-procedure
|
Percentage of procedures resulting in successful puncture and placement of an 8Fr locking pigtail nephrostomy catheter into the renal pelvicalyceal system using ultrasound guidance alone, confirmed by free drainage of urine and post-procedure imaging (ultrasound or KUB radiograph). |
24 hours post-procedure
|
|
Incidence of Procedure-Related Complications
時間枠：2 weeks post-procedure
|
Percentage of participants experiencing procedural or post-procedural complications, including major adverse events (severe retroperitoneal hemorrhage, urosepsis) and minor adverse events (persistent hematuria, tube displacement, or local puncture site infection). |
2 weeks post-procedure
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- US-Guided PCN in Oncology
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
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