# Radiation Oncology/Bile duct/Malignant Biliary Obstruction

* Front Page: Radiation Oncology | RTOG Trials | Randomized Trials

## Surgery

* Hiroshima Japan PMID 12827480 -- Analysis of longterm survivors with expandable metallic stent inserted for malignant biliary stenosis. (2003 Kawamoto H, J Hepatobiliary Pancreat Surg. 2003;10(1):95-100.)
** Retrospective. 111 patients treated with self-expandable metallic stents
** 24 patients (22%) survived >1 year. Dx bile duct CA or pancreatic CA. Complication duodenal obstruction
** Conclusion: "Many patients with bile duct carcinoma and pancreas carcinoma survived for more than 1 year and adjuvant therapy should be performed to improve the survival of those patients."
* Copenhagen Denmark PMID 2475392 -- Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice. (1989 Andersen JR, Gut. 1989 Aug;30(8):1132-5.)
** Randomized. 50 patients, 25 endoprosthesis vs. 25 bypass surgery
** No difference in survival
** Conclusion: "We conclude, that palliation of obstructive jaundice in malignant bile duct obstruction with endoscopically introduced endoprosthesis is as effective as operative bypass."
* PMID 2579449 -- Treatment of proximal biliary tract carcinoma: an overview of techniques and results. (1985 Ottow RT, Surgery. 1985 Mar;97(3):251-62.)
** Review of surgical palliative options (surgical bypass, percutaneous drainage, endoscopic stent)
** 15 series. Mean/median survival: 2-16 months. Average 8.6 months

## External Beam

* Tsukuba Japan PMID 11837580 -- External radiotherapy for decompression of cholangiocellular carcinoma with obstructive jaundice: report of a case. (2001 Nakayama H, Radiat Med. 2001 Nov-Dec;19(6):297-301.
** Case report of EBRT (60 Gy @ 2Gy/fx, delivered in 4F) use for obstructive jaundice
* Asahi Japan PMID 7590576 -- External radiotherapy for biliary decompression of hilar cholangiocarcinoma. (1995 Ohnishi H, Hepatogastroenterology. 1995 Jul;42(3):265-8.)
** Retrospective. 15 patients. EBRT 50-60 Gy with parallel opposing fields
** Toxicity: 3 patients d/c'd Rx for acute toxicity
** 1-year OS; 50%
** Conclusion: "This study suggests that external radiation therapy is an effective treatment for biliary decompression in patients with unresectable hilar cholangiocarcinoma."

## Brachytherapy

Randomized
* Brno, Czech Republic (1994-?) -- stent +/- intraluminal brachytherapy
** Randomized. 42 patients, obstruction, palliative intent. Arm 1) percutaneous self-expandable stent vs. Arm 2) stent + intraluminal BT Ir-192, mean 30 Gy over 4-5 days. Some also EBRT mean 50 Gy
** 2007 PMID 17344008 -- "Brachytherapy and percutaneous stenting in the treatment of cholangiocarcinoma: a prospective randomised study." (Valek V, Eur J Radiol. 2007 May;62(2):175-9. Epub 2007 Mar 6.)
*** Outcome: Mean OS 10 months vs. 13 months (SS). Stent patency 8 months vs. 12 months
*** Conclusion: Addition of RT could extend survival of patients with cholangiocarcinoma obstruction
Retrospective
* Turkey; 2005 PMID 15940068 -- "Intraluminal brachytherapy with metallic stenting in the palliative treatment of malignant obstruction of the bile duct." (Kocak Z, Radiat Med. 2005 May;23(3):200-7.)
** Retrospective. 8 patients, obstruction jaundice, treated with ILBT (10 Gy x1) followed by metallic stent
** 6/8 satisfactory control of jaundice; pain relief in 4/5; pruritis relief in 6/7
** Stent patency: median 5 months (4-14 months)
** Conclusion: HDR feasible, acceptable toxicity
* Shanghai; 2004 (2001-2002) PMID 15526374 -- "HDR-192Ir intraluminal brachytherapy in treatment of malignant obstructive jaundice." (Chen Y, World J Gastroenterol. 2004 Dec 1;10(23):3506-10.)
** Prospective. 34 patients post stent placement, 14 with ILRT and 20 control. Some patients of both groups received TACE
** Mean stent patency: ILRT 12.6 months vs. control 8.3 months (P<0.05).
** Mean survival: ILRT 9.4 months vs. control 6.0 months (p=NS). Minimal RT morbidity.
** Conclusion: HDR safe; it may prolong stent patency and survival
* Shanghai China PMID 15566681 -- [Clinical value of brachytherapy of malignant biliary obstruction after implanting expandable metallic biliary endoprothesis (EMBE)] - [Article in Chinese] (2004 Zhang FJ, Ai Zheng. 2004 Nov;23(11 Suppl):1567-71.)
** Prospective randomized. 49 patients with malignant biliary obstruction (17 HCC, 8 liver met, 18 CCA, 6 pancreatic CA) randomized to 1) EMBE, 2) EMBE + BT, 3) EMBE + RFA, 4) EMBE + catheter chemo
** Reobstruction rate: 46% vs. 25% vs. 22% vs. 27% (p<0.01)
** 1-year survival: 15% vs. 62% vs. 67% vs. 45% (p<0.01)
** Conclusion: "EMBE combined with brachytherapy is more effective methods than EMBE in treatment of malignant biliary obstruction."
* Chiba Japan PMID 15239222 -- Relief of jaundice by external beam radiotherapy and intraluminal brachytherapy in patients with extrahepatic cholangiocarcinoma: results without stenting. (2004 Ishii H, Hepatogastroenterology. 2004 Jul-Aug;51(58):954-7.)
** Prospective. 25 patients treated with EBRT (30 or 50 Gy) with BT (24-40 Gy). No stents
** Toxicity: cholangitis 10 patients (40%), gastroduodenal ulcer 2 (8%)
** 19 patients (76%) full patency. Tube-free survival median 76 days (7-468). Tube-free to OS ratio median 27% (2-80%). Median survival 9.3 months
** Conclusion: "Although there were limitations to the long-term relief of jaundice by this combined radiotherapy alone, tube-free status was achieved in some patients without stenting."
* Yokohama Japan PMID 11455465 -- Adjuvant therapies using biliary stenting for malignant biliary obstruction. (2001 Miura Y, J Hepatobiliary Pancreat Surg. 2001;8(2):113-7.)
** Retrospective. 29 patients (hilar 8, GB 11, pancreatic 10), with hyperthermia/RT, CT, or hyperthermia/RT+CT
** No significant difference in stent patency based on disease
** No impact of hyperthermia
** Stent patency: chemoradiation 182 days vs. no adjuvant 68 days (p=0.02)
** Median survival: chemoradiation 261 days vs. no adjuvant 109 days (p=0.03)
** Conclusion: "Adjuvant therapies such as radiotherapy and systemic chemotherapy, in combination with stent insertion, resulted in an increase in the patency period of expandable metallic stents and in increased patient survival time."
* Jefferson PMID 8756921 -- Malignant biliary duct obstruction: long-term experience with Gianturco stents and combined-modality radiation therapy. (1996 Eschelman DJ, Radiology. 1996 Sep;200(3):717-24.)
** Retrospective. 22 patients (11 CCA, 11 mets) treated with PCBD and BT 25 Gy, followed by stent. 11 patients also EBRT, 13 patients also CT
** Mean survival: CCA 22.6 months, mets 5.3 months
** Conclusion: "Radiation therapy including intraluminal Ir-192 appears to extend stent patency and survival in patients with inoperable cholangiocarcinoma treated with Gianturco metal stents compared with patients with other extrahepatic bile duct malignant diseases and patients treated without combined-modality therapy in other studies."
* Milan Italy 1990-93 PMID 7569076 -- [Transcutaneous radiotherapy combined with low dose intraluminal brachytherapy in the treatment of non-operable neoplastic stenoses of the bile ducts] - [Article in Italian] (1995 Tana S, Radiol Med (Torino). 1995 Jul-Aug;90(1-2):124-8.)
** Retrospective. 11 patients (8 CCA, 3 mets) treated with EBRT (40-60 Gy) and BT (6-25 Gy LDR)
** Drainage: 5 CR, 3 PR, 3 NR; Overall survival: 15 months
* New York PMID 2842216 -- Treatment of malignant biliary obstruction by endoscopic implantation of iridium 192 using a new double lumen endoprosthesis. (1988 Siegel JH, Gastrointest Endosc. 1988 Jul-Aug;34(4):301-6.)
** 15 patients (6 CCA, 4 pancreas, 4 ampulla) treated with BT (50 Gy over 48 hrs). No complications.
** Mean survival 7 months (0 - 27 months)
** Conclusion: "Because of proven efficacy of endoprostheses, this new technique should be considered when intraluminal irradiation is indicated."
* Japan PMID 3952640 -- [Intracavitary high dose rate afterloading irradiation of inoperable malignant bile duct obstruction] - [Article in German] (1986 Itami J, Strahlenther Onkol. 1986 Feb;162(2):105-10.)
** Case report of 7 patients
* MSKCC PMID 3942986 -- Intraluminal radiation therapy in the management of malignant biliary obstruction. (1986 Molt P, Cancer. 1986 Feb 1;57(3):536-44.)
** 15 patients, 8 primary disease (EHBD, GB, pancreas) and 7 metastatic disease. 11 patients EBRT 30 Gy + BT, 4 patients BT alone
** Median survival 4.5 months. No significant treatment toxicity
** Conclusion: "Analysis of this and other reports indicate the need for prospective controlled trials of the role of this regimen in the management of malignant biliary obstruction before wider application can be recommended."
* Stanford 1978-83 2579052 -- Malignant obstructive jaundice: treatment with external-beam and intracavitary radiotherapy. (1985 Johnson DW, Int J Radiat Oncol Biol Phys. 1985 Feb;11(2):411-6.)
** Retrospective. 11 patients treated with external drainage followed by EBRT 40-550 Gy + BT 31-106 Gy
** Complications: 27% UGIB
** Mean survival: 16.1 months from surgery, 8.3 months from RT (7-30 months)
** Conclusion: "High-dose external-beam therapy followed by high-dose Ir192 intracavitary boost is well tolerated and provides significant palliation."
* King's College Hospital PMID 6315122 -- Treatment of hilar carcinoma by bile drainage combined with internal radiotherapy using 192iridium wire. (1983 Fletcher MS, Br J Surg. 1983 Dec;70(12):733-5.)
** Retrospective. 19 patients (1 GB), treated with bile drainage + BT
** Median survival 11 months, 9 patients survival >12 months
** Conclusion: "The addition of internal radiotherapy may be beneficial to patients with hilar cholangiocarcinoma causing biliary obstruction in whom bile drainage can be established.
* PMID 7059949 -- A new method for treating carcinomatous biliary obstruction with intracatheter radium. (1982 Conroy RM, Cancer. 1982 Apr 1;49(7):1321-7.)
** Case report 6 patients. Radium needles placed in biliary drainage catheter x3 days