Bile duct cancer is often diagnosed after curative options are no longer available. Stent therapy is used to keep the ducts open and can be combined with photodynamic therapy (PDT) to extend life expectancy. PDT requires an injection of photosensitizer after which light of a particular wavelength is applied endoscopically to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat, also applied endoscopically. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively and no randomized trials exist comparing the two methods. This trial will compare survival in patients with a particular bile duct cancer depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.

开始日期2023-02-10

申办/合作机构

Universität Leipzig

JPRN-UMIN000044178 / RecruitingIIT

Comparison of the duration of recurrent bile duct obstruction between two 10 French Plastic Stent and fully covered Self expandable metallic stent for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud - Comparison of the duration of recurrent bile duct obstruction between two 10 French PS and fully covered SEMS for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud

开始日期2021-05-17

申办/合作机构

Jikei University School of Medicine

ISRCTN32669229 / CompletedN/AIIT

Palliative Chemotherapy (2nd line) with Imatinib (Glivec™) in Patients with Bile Duct Cancer

开始日期2006-03-01

申办/合作机构-

100 项与不能切除的胆管癌相关的临床结果

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100 项与不能切除的胆管癌相关的转化医学

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0 项与不能切除的胆管癌相关的专利（医药）

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项与不能切除的胆管癌相关的文献（医药）

2023-11-01·Annals of surgical oncology

A Multicenter Survey on Eligibility for a Randomized Phase III Trial of Adjuvant Chemotherapy for Resected Biliary Tract Cancer (JCOG1202, ASCOT).

Article

作者: Furuse, Junji ; Tomokuni, Akira ; Ueno, Makoto ; Satoi, Sohei ; Konishi, Masaru ; Ikeda, Masafumi ; Kobayashi, Shin ; Okusaka, Takuji ; Nakachi, Kohei ; Todaka, Akiko

BACKGROUNDThe Adjuvant S-1 for Cholangiocarcinoma Trial (JCOG1202, [ASCOT]) was a multicenter, randomized controlled trial aimed at investigating the efficacy and safety of adjuvant chemotherapy (AC) with S-1 for resected biliary tract cancer (BTC). This trial reported that overall survival was prolonged with AC compared with observation.METHODSWith the aim of increasing enrollment, the present survey biannually recorded the number of patients eligible for enrollment into ASCOT and reasons for ineligibility among patients who had undergone surgery for BTC from April 2015 to September 2017 at 36 institutions participating in ASCOT.RESULTSOf 2039 patients who underwent surgery for BTC, 211 (10.3%) were already enrolled, 166 (8.1%) were eligible but had not been enrolled, and 1662 (81.5%) were ineligible. Among ineligible patients, the predominant reasons for ineligibility were patient refusal (n = 332, 20.0%), pathologic stage (pT1N0; n = 248, 14.9%), age (≥ 81 years; n = 196, 11.8%), and prolonged postoperative complications (n = 176, 10.6%).CONCLUSIONSPatients undergoing surgery for BTC are a heterogeneous cohort comprising patients with earlier pathologic stage, advanced age, and prolonged postoperative complications. These factors should be considered during the design of future clinical trials of perioperative treatments for resectable BTC.

2023-09-01·Journal of the Chinese Medical Association

Cell-free DNA as a prognostic and predictive biomarker in resectable distal common bile duct cancer

Article

作者: Chen, Shih-Chin ; Shyr, Bor-Shiuan ; Wang, Shin-E ; Shyr, Yi-Ming ; Shyr, Bor-Uei

Background:Cell-free DNA (cfDNA) as an oncological biomarker has drawn much attention in recent years, but very limited effort has been made to investigate the prognostic values of cfDNA in distal common bile duct (CBD) cancer.Methods:Plasma cfDNA was measured in 67 patients with resectable distal CBD cancer. Survival outcomes and the correlation of cfDNA with other conventional prognostic factors were determined.Results:cfDNA levels were significantly higher in female patients, and those with poor tumor differentiation, abnormal serum carcinoembryonic antigen (CEA) level, and stage III cancer. The significant prognostic factors included a high cfDNA level (>8955 copies/mL), abnormal serum CEA level, stage III cancer, and positive resection margins. Compared with patients with high cfDNA level, those with lower cfDNA level (≤8955 copies/mL) had significantly better overall survival outcomes (74.4% vs 100% and 19.2% vs 52.6%, for 1- and 5-year survival rates, respectively, p = 0.001). The cfDNA level, perineural invasion, CEA level, and radicality were identified as independent prognostic factors for distal CBD cancer after multivariate analysis.Conclusion:Circulating cfDNA levels play a significant role in predicting the prognosis and survival outcome for resectable distal CBD cancer. Furthermore, acting as a promising liquid biopsy, cfDNA could serve as a prognostic and predictive biomarker in combination with current conventional markers to improve diagnostic and prognostic efficacy.

2023-02-01·European Journal of Surgical Oncology

Preoperative controlling nutritional status score predicts systemic disease recurrence in patients with resectable biliary tract cancer

Article

作者: Sakata, Jun ; Miura, Kohei ; Ishikawa, Hirosuke ; Wakai, Toshifumi ; Mito, Masato ; Miura, Yohei ; Kobayashi, Takashi ; Ichikawa, Hiroshi ; Hirose, Yuki ; Takizawa, Kazuyasu ; Saito, Seiji ; Shimada, Yoshifumi ; Abe, Shun

INTRODUCTIONThis study aimed to evaluate the association between the preoperative Controlling Nutritional Status (CONUT) score, survival outcomes, and recurrence pattern in patients with resectable biliary tract cancer (BTC).METHODSA total of 224 BTC patients (gallbladder, n = 69; intrahepatic bile ducts, n = 26; perihilar bile ducts, n = 72; distal bile duct, n = 57) who underwent surgery with curative intent were enrolled. The best cutoff point of the preoperative CONUT score in discriminating survival was determined using χ² scores. The sites of recurrence were subclassified as locoregional or distant.RESULTSPatients were subdivided into the CONUT-low (score ≤ 3, n = 156) and the CONUT-high (score > 3; n = 68) groups. In-hospital mortality occurred more frequently in the CONUT-high group than in the CONUT-low group (7.4% vs. 1.3%; p = 0.028). A high preoperative CONUT score was independently associated with worse overall survival (hazard ratio [HR] 1.906, p = 0.001), worse disease-specific survival (HR 1.840, p = 0.006), and worse recurrence-free survival (HR 1.680, p = 0.005). Recurrence developed in 110 (49.1%) patients. A high preoperative CONUT score was independently associated with a higher risk of distant recurrence (HR 2.245, p = 0.001), but not locoregional recurrence. The incidences of distant recurrence at 5 years were 55.4% and 34.2% in the CONUT-high and CONUT-low groups, respectively (p = 0.001).CONCLUSIONSThe preoperative CONUT score independently predicts survival outcomes and may serve as a surrogate marker of aggressive systemic disease recurrence in patients with resectable BTC.