NEW YORK (Reuters Health) Feb 10 - Compared with a conventional stent, a stent loaded with 125-iodine seeds stays patent longer and may prolong survival in patients with malignant biliary obstruction, a study from China suggests.
"The novel technique we designed is technically feasible and safe and may yield unexpected benefits in patients with unresectable malignant biliary obstruction who are usually considered for palliation treatments by most physicians," Dr. Gao-Jun Teng from Zhong-Da Hospital and Southeast University in Nanjing told Reuters Health in an email.
Dr. Teng and colleagues randomly assigned 24 patients with biliary obstruction due to various adenocarcinomas to receive either the irradiation stent with a conventional stent overlaying it, or a conventional self-expandable stent only.
The number, location, and activity of the radioactive seeds was determined individually for each patient, based on the size and extent of the tumor, the authors reported online January 17th in the Journal of Hepatology.
The technical success rate for stent placement was 100% in all 23 patients who remained in the study.
Three patients in the control group died in the first 11 days after stent placement. In everyone else, jaundice and pruritus disappeared gradually and performance status improved markedly.
After a median follow-up of 4.5 months, 16 of 23 patients died (7/12 in the irradiation group, 9/11 in the control group).
Median and mean overall survival rates, respectively, were 7.4 and 8.0 months in the irradiation stent group, compared with 2.5 and 3.4 months in the control group (p=0.006).
The overall complication rate was lower in the irradiation stent group than in the control group (5/11, 8.3% vs 45.5%), and there were no cases of stent migration or radioactive leak of the seeds.
All stents remained patent until the last follow-up or death, except in the three patients who died within two weeks of treatment.
"The preliminary result with this new 125I loaded stent is promising," Dr. Teng concluded. "However, a prospective, multicenter, randomized controlled clinical trial is mandatory (before this can become a) standard technique."
Dr. Teng said the new system still needs to be reviewed and approved by American and European regulators.
"There are several other treatment/palliation options currently, including external-beam radiotherapy, systemic chemotherapy, and conventional palliation stenting for relief of biliary tract obstruction, and stenting combined with chemotherapy or radiotherapy, besides a radical surgical resection," Dr. Teng said.
"Unfortunately, most such patients are unresectable," Dr. Teng added.
"I do not think the above therapies would reach the similar benefits as we did," Dr. Teng continued. "However, theoretically, the combination use of stenting and brachytherapy by implanting isotope seeds into the tumor may yield similar results except (there would be) the extra trauma and complications such as bleeding or infection caused by the procedure of the isotope seeds implantation."
The trial was supported by the National High-Tech Research Foundation of China and the Juangsu Provincial Medical Research Foundation of China.
SOURCE: http://bit.ly/wC84ce
J Hepatol 2012.
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