Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial

Endoscopy ◽  
2018 ◽  
Vol 50 (08) ◽  
pp. 751-760 ◽  
Author(s):  
Jianfeng Yang ◽  
Jing Wang ◽  
Haibin Zhou ◽  
Yifeng Zhou ◽  
Yang Wang ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Adverse Events ◽  
Survival Time ◽  
Hilar Cholangiocarcinoma ◽  
Palliative Treatment ◽  
Stent Group ◽  
Stent Patency ◽  
Extrahepatic Cholangiocarcinoma ◽  
Type Iii ◽  
Significant Difference

Abstract Background Endoscopic placement of biliary stents to relieve jaundice is the main palliative treatment for unresectable extrahepatic cholangiocarcinoma. Endoscopic biliary radiofrequency ablation (RFA) has been reported to prolong stent patency, which may be beneficial in improving patient survival. However, available evidence is still insufficient, as most reported studies are retrospective case series. The aim of this study was to explore the clinical effect and safety of RFA in patients with unresectable extrahepatic cholangiocarcinoma. Methods 65 patients with unresectable extrahepatic cholangiocarcinoma, except Bismuth type III and IV hilar cholangiocarcinoma, were enrolled and randomly underwent either RFA combined with biliary stenting (RFA + stent group; n = 32) or biliary stent only (stent-only group; n = 33). Overall survival time, stent patency period, and postoperative adverse events were recorded. Results In the 21-month follow-up period, the overall mean survival time was significantly longer in the RFA + stent group than in the stent-only group (13.2 ± 0.6 vs. 8.3 ± 0.5 months; P < 0.001). The mean stent patency period of the RFA + stent group was also significantly longer than that of the stent-only group (6.8 vs. 3.4 months; P = 0.02). There was no significant difference in the incidence of postoperative adverse events between the two groups (6.3 % [2/32] vs. 9.1 % [3/33]; P = 0.67). Conclusion Endoscopic RFA combined with stenting can significantly prolong survival and the stent patency period without increasing the incidence of adverse events in patients with extrahepatic cholangiocarcinoma patient, except Bismuth type III and IV hilar cholangiocarcinoma. This approach can be considered as a safe and effective palliative treatment for these patients.

scholarly journals Long-term results of ERCP- or PTCS-directed photodynamic therapy for unresectable hilar cholangiocarcinoma

2020 ◽  
Author(s):  
Zongyan Li ◽  
Xiaofeng Jiang ◽  
Hua Xiao ◽  
Shaoyi Chen ◽  
Wenfeng Zhu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Photodynamic Therapy ◽  
Adverse Events ◽  
Survival Time ◽  
Surgical Resection ◽  
Stent Placement ◽  
Median Survival Time ◽  
Hilar Cholangiocarcinoma ◽  
Stent Group

Abstract Background Photodynamic therapy (PDT) can be performed as palliative therapy for cholangiocarcinoma, while there is currently insufficient evidence for the efficacy. The aim of this study was to explore the clinical efficacy and safety of endoscopic retrograde cholangiopancreatography (ERCP)- or percutaneous transhepatic cholangioscopy (PTCS)-directed PDT combined with stent placement for unresectable hilar cholangiocarcinoma. Methods A retrospective analysis was conducted on 62 patients with unresectable hilar cholangiocarcinoma. Thirty patients received PDT using hematoporphyrin combined with biliary stent placement (PDT+stent group), including 22 receiving ERCP-directed PDT and 8 receiving PTCS-directed PDT. Survival time, quality of life, and postoperative adverse events were compared to 32 patients receiving biliary stent placement alone (Stent-only group). Results After 42 months of follow-up, median survival time was significantly longer in the PDT+stent group than the Stent-only group (14.2 vs. 9.8 months, P = 0.003). In the PDT+stent group, the median survival time was longer in the 6 patients with recurrence after surgical resection than the 24 patients without prior surgical resection (20.0 vs. 13.0 months, P = 0.017). The QOL total scores was significantly higher in the PDT+stent group than the Stent-only group at postoperative 6, 9, and 12 months (P<0.05). There was no significant difference in the incidence of postoperative adverse events between the two groups (24 [38.7%] vs. 20 [29.0%], P = 0.239). Conclusion ERCP- or PTCS-directed PDT + stent placement can prolong the survival of patients with unresectable hilar cholangiocarcinoma, especially those with recurrence and improve quality of life without increasing adverse events.

scholarly journals Hubungan ototoksisitas dan kemoterapi neoadjuvan pada karsinoma nasofaring berdasarkan ASHA, CTCAE, dan DPOAE

2018 ◽  
Vol 47 (2) ◽  
pp. 102
Author(s):  
Meyrna Heryaning Putri ◽  
Pudji Rahaju ◽  
Dyah Indrasworo
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Early Detection ◽  
Adverse Events ◽  
Otoacoustic Emissions ◽  
Pure Tone ◽  
Distortion Product Otoacoustic Emissions ◽  
Hearing Level ◽  
Type Iii ◽  
Distortion Product ◽  
Significant Difference

Latar belakang: Kemoterapi neoadjuvan adalah induksi kemoterapi sebelum radioterapi dengan regimen cisplatin dan 5-Fluorouracil. Kemoterapi cisplatin bersifat ototoksik pada pendengaran sensorineural bilateral progresif dan bersifat irreversible. Kriteria dari American Speech-Language Hearing Association (ASHA) dan Common Terminology Criteria for Adverse Events (CTCAE) merupakan kriteria untuk mengidentifikasi ototoksisitas dengan menggunakan audiometri, selain pemeriksaan Distortion Product Otoacoustic Emissions (DPOAE). Tujuan: Mengidentifikasi hubungan ototoksisitas dengan kemoterapi neoadjuvan pada penderita karsinoma nasofaring (KNF) WHO tipe III menggunakan ASHA, CTCAE, serta DPOAE. Metode: Studi ini adalah penelitian observasional dengan desain cohort. Kriteria inklusi penelitian yaitu penderita baru KNF WHO tipe III, yang mendapatkan kemoterapi regimen standar dan berusia <60 tahun. Kriteria pemeriksaan DPOAE adalah penderita dengan ambang dengar ≤40 dB. Percontoh dilakukan pemeriksaan timpanometri, audiometri, dan DPOAE. Hasil: Terdapat 9 sampel percontoh penelitian. Uji repeated-ANOVA menunjukkan tidak ditemukan perbedaan bermakna pada tiga hasil pengukuran audiometri antara pascakemoterapi pertama, kedua, dan ketiga (p>0,05). Deteksi awal ototoksisitas menggunakan kriteria ASHA menunjukkan sensitivitas sebesar 67% dan dan CTCAE 44%, dibandingkan baku emas menggunakan DPOAE. Kesimpulan: Ototoksisitas cisplatin ditemukan sejak kemoterapi pertama dengan menggunakan pemeriksaan DPOAE walaupun tidak bermakna secara statistik. Kemampuan DPOAE untuk mendeteksi awal ototoksisitas lebih baik dibandingkan kriteria ASHA dan CTCAE yang menggunakan audiometri nada murni.Kata kunci: Karsinoma nasofaring, ototoksisitas sisplatin, DPOAE, CTCAE, ASHA ABSTRACT Introduction: Neoadjuvant chemotherapy is induction chemotherapy before radiotherapy with cisplatin and 5-Fluorouracyl regiment. Chemotherapy cisplatin is ototoxic, leads to frequently progresive and irreversible bilateral sensorineural hearing loss. American Speech-Language Hearing Association (ASHA) and Common Terminology Criteria for Adverse Events (CTCAE) are the criteria to determine ototoxicity with audiometry, beside Distortion Product Otoacoustic Emissions (DPOAE). Purpose: To identify the relationship between ototoxicity with neoadjuvant chemotherapy in patients NPC WHO type III using ASHA, CTCAE, and DPOAE. Method: This observational study approach with cohort design. Inclusion criteria: new patients NPC WHO type III who consented to undergo standard regiment chemotherapy, and age <60 year-old. For DPOAE examination: hearing level ≤40 dB. Exclucion criteria: NPC WHO type III patients who underwent chemotherapy with unconventional standard regiment. Examinations for hearing function conducted with tympanometry, pure tone audiometry, and Distortion Product Otoacoustic Emissions (DPOAE). Result: There were 9 sample in this study. The result of Repeated-ANOVA test showed no significant difference in three audiometry measurements among three series of chemotherapies. Early detection of ototoxicity using ASHA and CTCAE criterias showed sensitivity of 67% and 44% (compared with DPOAE as a gold standard). Conclusion: Cisplatin ototoxicity had occured since the first chemotherapy and detected with DPOAE, but statistically was not significantly related. Early detection of cisplatin ototoxicity with DPOAE was much better than with criteria American Speech-Language Hearing Association (ASHA) and Common Terminology Criteria for Adverse Events (CTCAE), which used pure tone audiometry.Keywords: Nasopharyngeal carcinoma, cisplatin ototoxicity, DPOAE, CTCAE, ASHA

Radiofrequency Ablation vs Electrocautery Blinded Randomized Trial: Impact on Clinically Meaningful Outcomes

2020 ◽  
pp. 019459982096473
Author(s):  
Aaron J. Prussin ◽  
Eric Babajanian ◽  
Marc Error ◽  
J. Fredrik Grimmer ◽  
Jessica Ku ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Adverse Events ◽  
Medical Center ◽  
Academic Medical Center ◽  
Normal Activity ◽  
Inclusion Criteria ◽  
Pain Scores ◽  
Significant Difference ◽  
Monopolar Electrocautery ◽  
Daily Pain

Objective To analyze patients’ return to normal activity, pain scores, narcotic use, and adverse events after undergoing tonsillectomy or adenotonsillectomy with monopolar electrocautery or radiofrequency ablation. Study Design Randomized double-blinded clinical trial based on prospective parallel design. Setting Academic medical center and tertiary children’s hospital between March 2018 and July 2019. Methods Inclusion criteria included patients aged ≥3 years with surgical indication of recurrent tonsillitis or airway obstruction/sleep-disordered breathing. Patients were randomly assigned to monopolar electrocautery or radiofrequency ablation. Patients were blinded to treatment assignment. Survey questions answered via text or email were collected daily until postoperative day 15. The primary outcome was the patient’s return to normal activity. Secondary outcomes included daily pain score, total amount of postoperative narcotic use, and adverse events. Results Of the 236 patients who met inclusion criteria and were randomly assigned to radiofrequency ablation or monopolar electrocautery, 230 completed the study (radiofrequency ablation, n = 112; monopolar electrocautery, n = 118). There was no statistically significant difference between the groups in the number of days for return to normal activity ( P = .89), daily pain scores over 15 postoperative days ( P = .46), postoperative narcotic use ( P = .61), or return to hospital for any reason ( P = .60), including bleeding as an adverse event ( P = .13). Conclusions As one of the largest randomized controlled trials examining instrumentation in tonsillectomy, our data do not show a difference between monopolar electrocautery and radiofrequency ablation with regard to return to normal activity, daily pain scores, total postoperative narcotic use, or adverse events.

scholarly journals RT-02 POTENTIAL OF PROTON BEAM THERAPY FOR THE TREATMENT OF GLIOBLASTOMA

2019 ◽  
Vol 1 (Supplement_2) ◽  
pp. ii21-ii21
Author(s):  
Masahide Matsuda ◽  
Eiichi Ishikawa ◽  
Masashi Mizumoto ◽  
Hidehiro Kohzuki ◽  
Narushi Sugii ◽  
...  
Keyword(s):  
Local Recurrence ◽  
Adverse Events ◽  
Survival Time ◽  
Proton Beam ◽  
Radiation Necrosis ◽  
Proton Beam Therapy ◽  
High Dose ◽  
Failure Patterns ◽  
Survival Difference ◽  
Significant Difference

Abstract INTRODUCTION Recently, proton beam therapy has attracted increasing interest in the Japanese neuro-oncological field because of the insurance approval for pediatric brain tumor, chordoma, and chondrosarcoma. We have developed the high dose radiotherapeutic strategy using proton beam for malignant glioma in our institution since long before. Here we retrospectively analyzed the efficacy of this treatment strategy. METHODS Thirty-four patients with newly diagnosed GBM who underwent high dose proton beam therapy were investigated. All patients received hyperfractionated concomitant radiotherapy consisting of X-ray radiotherapy (50.4Gy in 28 fractions) and proton beam therapy (46.2Gy [RBE] in 28 fractions). Concurrent chemotherapy consisted of ACNU in the early 6 cases or TMZ in the late 28 cases. The survival outcome and adverse events were analyzed. RESULTS The median overall survival time and progression free survival time for all 34 patients were 35.7 months (95%CI, 28.1–43.4) and 11.2 months (95%CI, 6.8–15.7), respectively. No significant survival difference according to the chemotherapy regimen was shown. Failure patterns after proton beam therapy include 19 cases of local recurrence, 3 cases of distant recurrence, and 5 cases of dissemination. Although there was no significant difference in time to recurrence according to the failure pattern, there was a tendency of longer survival in the local recurrence group. As for adverse events, symptomatic radiation necrosis was observed in 9 cases. The median time to onset of necrosis after radiation was 18.2 months (95%CI, 10.2–26.2). There were 8 cases of long survivors over 5 years out of 34 cases (23.5%). Of these, 6 cases developed symptomatic radiation necrosis. CONCLUSIONS Our results indicate that high dose proton beam therapy of 96.6Gy (RBE) prolonged survival in selected GBM patients. With appropriate patient selection and potent treatment for radiation necrosis, high dose proton beam therapy has a great potential to improve survival in GBM patients.

scholarly journals RT-4 Treatment outcome of proton beam therapy for glioblastoma

2021 ◽  
Vol 3 (Supplement_6) ◽  
pp. vi15-vi15
Author(s):  
Masahide Matsuda ◽  
Masashi Mizumoto ◽  
Hidehiro Kohzuki ◽  
Narushi Sugii ◽  
Eiichi Ishikawa
Keyword(s):  
Local Recurrence ◽  
Adverse Events ◽  
Survival Time ◽  
Proton Beam ◽  
Radiation Necrosis ◽  
Methylation Status ◽  
Proton Beam Therapy ◽  
High Dose ◽  
Failure Patterns ◽  
Significant Difference

Abstract Introduction: Proton beam therapy enables high dose irradiation for tumors while reducing the dose to surrounding normal tissue due to the sharp energy peak called the Bragg peak. We retrospectively analyzed the efficacy of the high dose radiotherapeutic strategy using proton beam for glioblastoma (GBM) in our institution. Methods: Twenty-nine patients with newly diagnosed GBM who underwent high dose proton beam therapy concomitant with temozolomide were investigated. All patients received hyperfractionated concomitant radiotherapy consisting of X-ray radiotherapy (50.4Gy in 28 fractions) and proton beam therapy (46.2Gy [RBE] in 28 fractions). The survival outcome and adverse events were analyzed. Results: The median overall survival time and progression free survival time for all 29 patients were 31.0 months (95%CI, 25.9–36.1) and 11.0 months (95%CI, 7.8–14.2), respectively. No significant survival difference according to the MGMT methylation status was shown. Failure patterns after proton beam therapy included 17 cases of local recurrence, 3 cases of distant recurrence, and 5 cases of dissemination. Although there was no significant difference in time to recurrence according to the failure pattern, there was a tendency of longer survival in the local recurrence group. Regarding adverse events, radiation necrosis was observed in 8 cases (including 2 asymptomatic cases). The median time to onset of necrosis after radiation was 18.2 months (95%CI, 10.3–26.2). There were 5 cases of long survivor over 5 years out of 29 cases (17.2%). Of these, 4 cases developed radiation necrosis. Conclusions: Our results indicate that high dose proton beam therapy of 96.6Gy (RBE) prolonged survival in selected GBM patients. Particularly in long survivors, special attention and effective treatment to radiation necrosis is a remaining problem.

scholarly journals Metformin Use and Survival in Patients with Advanced Extrahepatic Cholangiocarcinoma: A Single-Center Cohort Study in Fuyang, China

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Jinqing Wu ◽  
Yabo Zhou ◽  
Guizhou Wang
Keyword(s):  
Survival Time ◽  
Clinical Information ◽  
Control Group ◽  
Extrahepatic Cholangiocarcinoma ◽  
Oral Antidiabetic Agent ◽  
Survival Prognosis ◽  
Anticancer Properties ◽  
Control Subjects ◽  
Imaging Results ◽  
Significant Difference

Aims. Metformin is an oral antidiabetic agent that has been widely prescribed for the treatment of type II diabetes. In recent years, anticancer properties of metformin have been revealed for numerous human malignancies. However, there are few indications available regarding the feasibility and safety of these studies in an advanced extrahepatic cholangiocarcinoma (EHCC) population. This study is aimed at evaluating the feasibility, safety, and value of metformin use and survival in patients with advanced EHCC. Methods. All patients with advanced EHCC observed at Fuyang People’s Hospital between January 2015 and November 2020 were included in the study. Case data, clinical information, and imaging results were abstracted from the self-administered questionnaire and electronic medical record. All patients were divided into study subjects and control subjects, and the study subjects were given metformin, 0.5 g, three times a day, while control subjects were without metformin. The metformin use and survival time of the subjects were asked by telephone, out-patient, or door-to-door visit, after they left the hospital. Results. One hundred and thirty-three study cases and 589 controls were included in the analysis. This study showed that metformin use cannot improve the overall survival rate of patients with advanced EHCC ([95% CI]: -17.05-0.375, t = − 1.889 , P value = 0.061), but the survival time of patients with drainage treatment from control group ( n = 496 ) was significantly shorter than that of patients with drainage treatment from the study group ( n = 113 ), and the difference was statistically significant ( z = − 2.230 , P value = 0.026). There were significant differences between metformin used before or after the diagnosis of advanced EHCC (OR[95% CI], 3.432[2.617-4.502]; P value = 0.001) in survival time. And there was significant difference between the duration of metformin use and survival prognosis (OR[95% CI], 2.967[1.383-6.368]; P = 0.005 ). Conclusion. Metformin can improve the survival of advanced EHCC patients who underwent drainage treatment, especially for metformin use after diagnosis of advanced EHCC and long duration of metformin.

scholarly journals Covered Stents versus Uncovered Stents for Unresectable Malignant Biliary Strictures: A Meta-Analysis

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Ming-Yu Chen ◽  
Jia-Wei Lin ◽  
He-Pan Zhu ◽  
Bin Zhang ◽  
Guang-Yi Jiang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Patient Survival ◽  
Meta Analysis ◽  
Covered Stents ◽  
Random Effects Model ◽  
Biliary Strictures ◽  
Stent Patency ◽  
Sems Group ◽  
Uncovered Stents ◽  
Significant Difference

Aim. To summarize the covered or uncovered SEMS for treatment of unresectable malignant distal biliary obstruction, comparing the stent patency, patient survival, and incidence of adverse events between the two SEMSs.Methods. The meta-analysis search was performed independently by two of the authors, using MEDLINE, EMBASE, OVID, and Cochrane databases on all studies between 2010 and 2015. Pooled effect was calculated using either the fixed or the random effects model.Results. Statistics shows that there is no difference between SEMSs in the hazard ratio for patient survival (HR 1.04; 95% CI, 0.92–1.17;P=0.55) and stent patency (HR 0.87, 95% CI: 0.58 to 1.30,P=0.5). However, incidence of adverse events (OR: 0.74, 95% CI: 0.57 to 0.97,P=0.03) showed significant different results in the covered SEMS, with dysfunctions events (OR: 0.75, 95% CI: 0.56 to 1.00,P=0.05) playing a more important role than complications (OR: 0.87, 95% CI: 0.58 to 1.30,P=0.50).Conclusions. Covered SEMS group had lower incidence of adverse events. There is no significant difference in dysfunctions, but covered SEMS trends to be better, with no difference in stent patency, patient survival, and complications.

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