Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial) (SMART-B)
Randomized Clinical Trial of Suprapapillary Drainage With Metal Stent vs. Routine Internal-External Transpapillary Drainage in Patients With Malignant Hilar Biliary Obstruction
Malignant hilar biliary obstruction is a condition in which the bile ducts near the liver become blocked due to cancer. This blockage can lead to jaundice (yellowing of the skin and eyes), itching, infection, and impaired liver function. To relieve the obstruction, doctors commonly perform procedures to drain bile and restore its flow.
There are different techniques available for biliary drainage. One common method is percutaneous transpapillary internal-external drainage, in which a catheter is placed through the liver and across the natural opening of the bile duct into the intestine. Another approach is percutaneous suprapapillary drainage using a self-expanding metal stent, which allows bile to drain without crossing into the intestine and may reduce the risk of contamination and infection.
Currently, there is no clear consensus on which of these two techniques is safer or more effective for patients with malignant proximal biliary obstruction. Some studies suggest that avoiding manipulation of the intestinal opening of the bile duct may reduce complications such as infection, but high-quality comparative evidence is lacking.
The purpose of this study is to compare percutaneous suprapapillary drainage with a self-expanding metal stent versus routine percutaneous transpapillary internal-external drainage in patients with malignant proximal biliary obstruction. The study aims to compare the rate of drainage-related complications between the two techniques, as well as to evaluate treatment success, stent patency, and the need for reintervention. In addition, in patients with potentially resectable disease undergoing preoperative biliary drainage, the study will assess and compare surgical outcomes between the two approaches. The results of this study may help determine the safest and most effective drainage strategy for these patients and improve future clinical decision-making.
調査の概要
状態
詳細な説明
Malignant hilar biliary obstruction is most commonly associated with perihilar cholangiocarcinoma and represents a complex clinical condition characterized by impaired bile flow at or above the hepatic duct confluence. The resulting cholestasis may lead to progressive hepatic dysfunction, increased risk of infectious complications, and reduced tolerance to systemic or surgical therapies. In selected patients, preoperative biliary drainage is performed to optimize liver function and reduce perioperative risk prior to major hepatectomy.
Percutaneous biliary drainage is widely used in this setting due to its ability to selectively decompress specific hepatic segments, particularly in complex hilar strictures. The conventional approach consists of transpapillary internal-external drainage, in which a catheter is advanced across the obstruction and through the papilla into the duodenum. While effective in achieving biliary decompression, this technique may disrupt the function of the sphincter of Oddi and facilitate duodenobiliary reflux, which has been implicated as a potential mechanism for infectious complications.
Percutaneous suprapapillary drainage with placement of a self-expanding metal stent represents an alternative strategy. By avoiding transpapillary manipulation, this approach preserves sphincter function and may reduce bacterial contamination of the biliary tree. Early clinical data suggest a favorable safety profile, particularly regarding infectious outcomes; however, direct comparisons with conventional transpapillary drainage remain limited, and available studies are constrained by methodological limitations.
An additional area of uncertainty relates to patients with potentially resectable disease. In this subgroup, the choice of drainage technique may influence not only peri-procedural outcomes but also subsequent surgical management. Concerns have been raised regarding the potential impact of metallic stents on operative complexity and resectability, although robust data are lacking.
This randomized clinical trial is designed to compare two percutaneous drainage strategies within a standardized institutional framework. Patients with an indication for percutaneous biliary drainage will be allocated to receive either transpapillary internal-external drainage or suprapapillary drainage with a self-expanding metal stent. The study includes both patients with unresectable disease and those with potentially resectable malignancies, allowing for evaluation across different clinical scenarios.
All procedures will be performed by experienced interventional radiologists using uniform technical protocols, and patients will be managed according to institutional standards of care. Follow-up will include clinical, laboratory, and imaging assessment as appropriate to routine practice.
The study is designed to generate comparative evidence regarding the safety and performance of these two techniques. In addition, a prespecified subgroup analysis will focus on patients with potentially resectable cholangiocarcinoma undergoing preoperative biliary drainage, in order to explore the impact of drainage strategy on subsequent surgical outcomes.
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：Cleber R. P. Kruel, Professor
- 電話番号：8232 +55(51)3359-8232
- メール：crkruel@hcpa.edu.br
研究連絡先のバックアップ
- 名前：Gabriel L. da Silva, Attending Physician
- 電話番号：8232 +55(51)3359-8232
- メール：gablsilva@hcpa.edu.br
研究場所
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル、90035-903
- Hospital de Clinicas de Porto Alegre
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コンタクト：
- Cleber R. P. Kruel, Professor
- 電話番号：8232 +55(51)3359-8232
- メール：crkruel@hcpa.edu.br
-
コンタクト：
- Gabriel L. da Silva, Attending Physician
- 電話番号：8232 +55(51)3359-8232
- メール：gablsilva@hcpa.edu.br
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副調査官：
- Gabriel L. da Silva, Attending Physician
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副調査官：
- Leandro A. Scaffaro, Attending Physician
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副調査官：
- Mauricio Farenzena, Attending Physician
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副調査官：
- Flavia H. Feier, Professor
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副調査官：
- Pablo D. Rodrigues, Attending Physician
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副調査官：
- Tomaz J. M. Grezzana, Attending Physician
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副調査官：
- Marcio F. Chedid, Attending Physician
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副調査官：
- William F. Silvano, Attending Physician
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副調査官：
- Francisco C. B. Lemanski, General Surgery Resident
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主任研究者：
- Cleber R. P. Kruel, Professor
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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:
- Age >18 years.
- Malignant proximal biliary obstruction on imaging (magnetic resonance cholangiopancreatography or contrast-enhanced abdominal computed tomography) with histopathological confirmation or high clinical and radiological suspicion.
- Total bilirubin > 3 mg/dL.
- Patients not candidates for potentially curative surgical resection due to locally advanced disease, metastatic disease, or inadequate clinical condition.
- Patients with potentially resectable neoplasms, defined as the possibility of achieving complete resection (R0), who meet at least one of the following criteria:
5.1 Estimated future liver remnant <40%, in whom percutaneous portal vein embolization of the side to be resected will also be indicated after initial drainage.
5.2 Prolonged jaundice with total bilirubin >10 mg/dL for more than 14 days. 5.3 Malnutrition, defined as ≥10% unintentional weight loss or albumin <3 g/dL, presumably attributable to cholestasis.
5.4 Indication for neoadjuvant chemotherapy.
Exclusion Criteria:
- Tumor with distal extension to the duodenal papilla, precluding suprapapillary drainage.
- Prior biliary drainage procedure, either percutaneous (PTBD) or endoscopic (ERCP).
- Acute cholangitis, clinically defined as fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³).
- Uncorrectable coagulopathy.
- Iodinated contrast allergy not amenable to desensitization.
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Transpapillary internal-external drainage
Participants undergo percutaneous transpapillary internal-external biliary drainage with placement of a catheter across the obstruction and through the papilla into the duodenum, according to standard institutional practice.
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Percutaneous biliary drainage performed by advancing a catheter across the biliary obstruction and through the papilla into the duodenum, allowing internal and external bile drainage.
他の名前：
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アクティブコンパレータ：Suprapapillary Self-Expanding Metal Stent Drainage
Participants undergo percutaneous suprapapillary biliary drainage with placement of a self-expanding metal stent across the obstruction without crossing the papilla.
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Percutaneous biliary drainage performed by placing a self-expanding metal stent across the biliary obstruction without crossing the papilla.
他の名前：
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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 |
|---|---|---|
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Acute cholangitis
時間枠：Within 90 days after intervention
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Defined by clinical criteria, including fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³), in the absence of another infectious source on abdominal and chest imaging.
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Within 90 days after intervention
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Acute cholecystitis
時間枠：Within 90 days after intervention
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Defined by radiological evidence of cholecystitis associated with fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³).
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Within 90 days after intervention
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Acute pancreatitis
時間枠：Within 90 days after intervention
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Defined by the presence of at least two of the following criteria: abdominal pain consistent with pancreatitis, elevation of amylase and/or lipase greater than three times the upper limit of normal, or characteristic imaging findings.
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Within 90 days after intervention
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Bile leak
時間枠：Within 90 days after intervention
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Defined as intra-abdominal bile leakage due to biliary perforation or at the hepatic puncture site, confirmed by imaging.
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Within 90 days after intervention
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Hemorrhage
時間枠：Within 90 days after intervention
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Defined as clinical or radiological evidence of bleeding requiring blood transfusion or reintervention.
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Within 90 days after intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Therapeutic success
時間枠：Within 30 days after intervention
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Defined as a decrease in total bilirubin to <3 mg/dL or a reduction of more than 50% compared to pre-drainage levels
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Within 30 days after intervention
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Mortality
時間枠：Within 90 days after intervention
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All-cause mortality following biliary drainage.
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Within 90 days after intervention
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Need for reintervention
時間枠：Within 30 days after intervention
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Requirement for additional percutaneous or endoscopic procedures
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Within 30 days after intervention
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rate of curative surgery
時間枠：Within 180 days of intervention
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Number of patients from group A (patients with potentially resectable neoplasms) who undergo potentially curative surgery
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Within 180 days of intervention
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90-day postoperative mortality
時間枠：Within 90 days of curative surgery
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Surgical mortality in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially curative surgery
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Within 90 days of curative surgery
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90-day postoperative morbidity
時間枠：Within 90 days of curative surgery
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Surgical morbidity in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially curative surgery according to Clavien-Dindo classification
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Within 90 days of curative surgery
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Incidence of postoperative liver failure
時間枠：Within 90 days of curative surgery
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Incidence of postoperative liver failure in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially resectable surgery
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Within 90 days of curative surgery
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Stent patency duration
時間枠：Within 180 days of intervention
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Duration of stent patency in patients from group B (patients not candidates for potentially curative resection)
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Within 180 days of intervention
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協力者と研究者
捜査官
- スタディチェア：Cleber R. P. Kruel, Professor、Hospital de Clinicas de Porto Alegre
出版物と役立つリンク
一般刊行物
- Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
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- Zhao XQ, Dong JH, Jiang K, Huang XQ, Zhang WZ. Comparison of percutaneous transhepatic biliary drainage and endoscopic biliary drainage in the management of malignant biliary tract obstruction: a meta-analysis. Dig Endosc. 2015 Jan;27(1):137-45. doi: 10.1111/den.12320. Epub 2014 Sep 24.
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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
キーワード
その他の研究ID番号
- 2025-0661
- 95412526.6.0000.5327 (その他の識別子：Plataforma Brasil)
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
Access to individual participant data (IPD) and supporting documents (including the study protocol and statistical analysis plan) will be granted to researchers who provide a methodologically sound research proposal. Requests must specify the intended use of the data and will be reviewed by the study investigators in accordance with institutional policies.
Data will be shared in a de-identified format to ensure participant confidentiality. Access will be provided upon reasonable request to the corresponding author, subject to approval by the investigators and applicable ethical and legal requirements. Data will be made available through secure data transfer methods.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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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