Clinical trial · Interventional
Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma
Observational Study for Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma
NCT01506115CI-TRIAL-00019881completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The prognosis of patients with obstructive jaundice caused by hepatocellular carcinoma (HCC) is dismal even after biliary drainage; due to malfunction of the biliary drainage tube caused by hemobilia and/or tumor emboli. Photodynamic therapy (PDT) in hilar cholangiocarcinoma improves biliary drainage and prolongs survival. The aims of this study were to assess the safety and efficacy of PDT in unresectable HCC with bile duct invasion.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Obstructive Jaundice | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photofrin | Drug | Porfimer | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HCC with bile duct invasion
- description
- Photodynamic therapy with biliary drainage in patients with bile duct invasion of unresectable HCC
- interventionNames
- Drug: Photofrin
Primary outcomes (1)
- measure
- Complications associated with the procedure
- timeFrame
- Six months
- description
- * Procedure related cholangitis: fever accompanied by biliary pain that developed within three days after PDT without other infection * Procedure related pancreatitis: abdominal pain and increases in amylase and lipase levels threefold higher than normal * Procedure related bleeding: more than a 5% decrease in hematocrit compared to the initial value and coexisting bleeding on abdominal CT or endoscopy * Complications associated with the photosensitizer: classified as photosensitivity, burn, and pigmentation
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Known HCC: Diagnosis of HCC based on the 2005 AASLD (American Association for the Study of Liver Diseases) practice guidelines * Unresectable HCC: Determined based on the BCLC (Barcelona-Clinic-Liver-Cancer) staging and treatment system * Bile duct invasion of HCC: Confirmed by pathology via endoscopic retrograde cholangiopancreatogram (ERCP) or percutaneous transhepatic biliary drainage (PTBD). In case pathological diagnosis is clinically impossible, confirmed by dynamic CT or MRI showing that typical arterial enhancing mass in dilated bile duct and previous HCC diagnosis. Exclusion Criteria: * Severe renal disease * Severe cardiac disease * Bleeding tendency * Porphyria
References
Publications (23)
- BACKGROUNDEl-Serag HB. Hepatocellular carcinoma. N Engl J Med. 2011 Sep 22;365(12):1118-27. doi: 10.1056/NEJMra1001683. No abstract available. PMID 21992124
- BACKGROUNDSingal AG, Marrero JA. Recent advances in the treatment of hepatocellular carcinoma. Curr Opin Gastroenterol. 2010 May;26(3):189-95. doi: 10.1097/MOG.0b013e3283383ca5. PMID 20224395
- BACKGROUNDLai EC, Lau WY. Hepatocellular carcinoma presenting with obstructive jaundice. ANZ J Surg. 2006 Jul;76(7):631-6. doi: 10.1111/j.1445-2197.2006.03794.x. PMID 16813631
- BACKGROUNDQin LX, Tang ZY. Hepatocellular carcinoma with obstructive jaundice: diagnosis, treatment and prognosis. World J Gastroenterol. 2003 Mar;9(3):385-91. doi: 10.3748/wjg.v9.i3.385. PMID 12632482
- BACKGROUNDLau WY, Leow CK, Leung KL, Leung TW, Chan M, Yu SC. Cholangiographic features in the diagnosis and management of obstructive icteric type hepatocellular carcinoma. HPB Surg. 2000;11(5):299-306. doi: 10.1155/2000/79241. PMID 10674744
- BACKGROUNDLau WY, Leung JW, Li AK. Management of hepatocellular carcinoma presenting as obstructive jaundice. Am J Surg. 1990 Sep;160(3):280-2. doi: 10.1016/s0002-9610(06)80023-1. PMID 2168129
- BACKGROUNDLau W, Leung K, Leung TW, Liew CT, Chan MS, Yu SC, Li AK. A logical approach to hepatocellular carcinoma presenting with jaundice. Ann Surg. 1997 Mar;225(3):281-5. doi: 10.1097/00000658-199703000-00007. PMID 9060584
- BACKGROUNDCho HC, Lee JK, Lee KH, Lee KT, Paik S, Choo SW, Do YS, Choo IW. Are endoscopic or percutaneous biliary drainage effective for obstructive jaundice caused by hepatocellular carcinoma? Eur J Gastroenterol Hepatol. 2011 Mar;23(3):224-31. doi: 10.1097/MEG.0b013e3283436ff6.