Comparative Study of Percutaneous Transhepatic Biliary Stent Placement with or without Iodine-125 Seeds for Treating Patients with Malignant Biliary Obstruction

doi:10.1016/j.jvir.2016.11.038

Journal of Vascular and Interventional Radiology

Volume 28, Issue 4, April 2017, Pages 583-593

https://doi.org/10.1016/j.jvir.2016.11.038 Get rights and content

Abstract

Purpose

To prospectively evaluate safety and efficacy of biliary stent placement with iodine-125 (¹²⁵I) seeds in patients with malignant obstructive jaundice (MOJ).

Materials and Methods

From July 2011 to June 2014, 55 patients were enrolled (group A, 11 men and 17 women, mean age 70.93 y ± 8.58; group B, 14 men and 13 women, mean age 70.26 y ± 9.71). All patients were randomly assigned to placement of a biliary stent with ¹²⁵I seeds (group A) or biliary stent only (group B). After stent placement, outcomes were measured regarding relief of MOJ. Clinical success rate, survival time, and safety were recorded. P < .05 was considered to indicate significant difference.

Results

Stents were successfully placed in all 55 patients. MOJ was relieved in all patients, and there were no significant differences in complications related to stent insertion between the 2 groups. Mean and median stent patency were 191 days ± 19.8 (95% confidence interval [CI], 152–230 d) and 179 days ± 191.4 (95% CI, 87–267 d) in group A and 88.3 days ± 16.3 (95% CI, 61–114 d) and 77 days ± 88.2 (95% CI, 65–86 d) in group B (P < .001, log-rank test). Mean and median survival time were 222.6 days ± 21.0 (95% CI, 181–263 d) and 241 days ± 18.2 (95% CI, 179–270 d) in group A and 139.1 days ± 14.5 (95% CI, 110–167 d) and 142 days ± 16.3 (95% CI, 83–177 d) in group B (P < .001, log-rank test).

Conclusions

¹²⁵I seeds combined with biliary stent placement could significantly improve stent patency. The procedure seems to be safe and to extend survival compared with self-expandable biliary stent placement.

Section snippets

Materials and Methods

This prospective study was approved by the ethical committee of our hospital and was registered as a Chinese clinical trial (registration no. ChiCTR-TRC-11001456), for which each patient provided written informed consent.

Results

The stents combined with ¹²⁵I seed strand were implanted in the malignant biliary obstruction of 28 patients (group A), and the remaining 27 patients were implanted with stents only (group B). Mean 15.46 ± 2.30 (range, 9–18) ¹²⁵I seeds were implanted in each patient (Table 3). The technical success rate of stent placement was 100% in all patients. None of the ¹²⁵I seeds were lost during the delivery and deployment process. Combined single photon emission computed tomography/CT scan performed 1

Discussion

Despite progress in diagnostic and therapeutic options made in recent decades, the prognosis for patients with MOJ remains poor. The current treatment options for MOJ include surgery, interventional therapy with biliary stent placement, and endoscopic therapy. Although surgery can relieve jaundice in addition to removing lesions and peripheral vascular invasion (17), biliary stent placement is the preferred treatment for patients with MOJ who have unresectable tumors or who are unwilling to

Acknowledgments

We thank Dr. Shayahati Bieerkehazhi (Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, Texas) for editing our manuscript.

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Cited by (34)

A stent with radioactive seed strand insertion for inoperable malignant biliary obstruction: A meta-analysis
2021, Brachytherapy
Citation Excerpt :
We initially identified 196 potentially relevant studies, of which nine studies were selected in this meta-analysis (Fig. 1). Of these studies, three were RCTs (10, 12, 13) and six were retrospective analyses (11, 14–18). In total, these studies included 643 patients with MBO (280 and 363 who underwent stent insertion with and without RSS insertion, respectively) (Table 1).
The purpose of the study was to assess the relative clinical effectiveness of stent insertion with or without radioactive seed strand (RSS) insertion in patients suffering from malignant biliary obstruction (MBO).
Relevant articles published as of November 2020 in the Embase, PubMed, and Cochrane Library databases were identified and analyzed. Primary study endpoints for this meta-analysis were stent dysfunction, stent patency, and overall survival (OS), whereas secondary endpoints were rates of clinical success and complications. RevMan v5.3 was used to perform all meta-analyses.
In total, there were nine studies incorporating 643 patients (280 and 363 who underwent stent insertion with and without RSS, respectively). No differences were observed between these groups with respect to pooled rates of clinical success (p = 0.25), stent dysfunction (p = 0.47), cholangitis (p = 0.97), cholecystitis (p = 0.95), or pancreatitis (p = 0.66). However, stent patency duration (p < 0.00001) and patients’ OS (p < 0.00001) were significantly increased in patients in the stent + RSS group. No heterogeneity was detected for any of these endpoints, nor did funnel plots yield any publication bias. A subgroup analysis of patients with hilar MBO similarly exhibited stent + RSS insertion to be associated with longer stent patency and OS as compared with stent insertion alone.
These findings showed that relative to stent insertion, stent + RSS insertion is associated with longer OS and stent patency in patients with inoperable MBO.
An iodine-125 seed strand combined with a metal stent versus a metal stent alone for obstructive jaundice caused by pancreatic ductal adenocarcinoma
2021, Brachytherapy
Citation Excerpt :
It has demonstrated that the biliary stent loaded with 125I seeds can offer a significant improvement in swallowing function and increased stent patency for patients with MOJ compared with stent placement alone (12, 20–23). For instance, some studies (13–15, 20, 22, 24–32) showed that an 125I seed strand combined with a metal stent prolonged stent patency and decreased reinterventions compared with a metal stent in MOJ. However, these studies included patients with MOJ caused by cholangiocarcinoma, PDAC, and metastatic cancer or analyzed the efficacy of an 125I seed strand combined with a metal stent only (14, 15, 28–32) without comparing with a metal stent.
The purpose of this study was to assess the efficacy of an iodine-125 (¹²⁵I) seed strand combined with a metal stent compared with a metal stent for treatment of obstructive jaundice caused by pancreatic ductal adenocarcinoma (PDAC).
A retrospective analysis was carried out of patients who were referred to Shanghai Zhongshan Hospital of Fudan University with a diagnosis of PDAC between January 1, 2010 and January 31, 2019. A total of 110 consecutive patients with obstructive jaundice caused by PDAC were divided into the iodine-125 seed strand combined with a metal stent group (Group A = 48) and the metal stent group (Group B = 62). The primary outcome was stent obstruction–free survival time, and secondary outcomes were overall survival and complications.
The median stent obstruction–free survival time was 133.0 (95% confidence interval (CI): 166.093–149.907) days, and the median overall survival was 212.0 (95% CI: 187.183–236.817) days in all patients. Median stent obstruction–free survival time was 175 days (95% CI 103.165–246.835 days) in Group A versus 120 days (95% CI 87.475–152.525 days) in Group B (p = 0.035). A lower Eastern Cooperative Oncology Group (ECOG) score (p = 0. 000) and iodine-125 seed strand combined with metal stent implantation (p = 0.008) were associated with a longer stent obstruction–free survival time. Obstruction length (p = 0.083), ECOG score (p = 0.000), and iodine-125 seeds (p = 0.037) might have potential impact on stent obstruction–free survival time and were included for multivariable analysis using the Cox proportional hazards model. Stent restenosis was observed in 18.8% (9/48) of patients in Group A and 54.8% (34/62) in Group B, respectively. There was no significant difference in median survival between Group A and Group B (p = 0.409). The median survival in Group A was 209 days (95% CI 150.750–267.250) and 202 days (95% CI 190.624–233.376) in Group B. The median survival of patients with a lower ECOG score was better than that of patients with a higher ECOG score (267 days vs 132 days, p = 0.000). The Grade 3 or 4 complications occurred in 4 (8.3%) of the 48 patients in Group A (one case of hemobilia, one case of liver abscess, two cases of choleperitonitis) and in 5 (8.1%) of the 62 patients in Group B (one case of hemobilia, two cases of liver abscess, two cases of choleperitonitis) (p = 0.972).
Implantation of an iodine-125 seed strand combined with a metal stent provides longer obstruction-free survival time compared with a metal stent in patients with obstructive jaundice caused by PDAC. It seems reasonable to choose an iodine-125 seed strand combined with a metal stent as a treatment for these patients.
No Advantage of Expanded Polytetrafluoroethylene and Fluorinated Ethylene Propylene–Covered Stents over Uncovered Nitinol Stents for Percutaneous Palliation of Malignant Infrahilar Biliary Obstruction: Results of a Single-Center Prospective Randomized Trial
2020, Journal of Vascular and Interventional Radiology
Citation Excerpt :
The decision for stent placement should be based on patient condition and the prospect of chemotherapy. Whether drug-eluting stents or stents combined with locoregional therapy (eg, radiofrequency ablation, brachytherapy) will significantly improve patency and hence the odds for chemotherapy is still to be answered (30–32). It might be that novel endoscopic US-guided techniques will seriously challenge the percutaneous approach, but the endoscopists will also have to find a solution for the covered stent dysfunctions described (33,34).
To prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction.
After failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene–covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared.
Three patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178–438 d) for covered and 442 d (95% CI, 172–712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68–124 d) with covered stents and 75 days (95% CI, 42–108 d) with uncovered stents (P = .6).
In malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.
Safety and efficacy of self-expandable metallic stent combined with <sup>125</sup>I brachytherapy for the treatment of malignant obstructive jaundice
2023, Cancer Imaging
Biliary self-expandable metallic stent combined with iodine-125 seeds in the treatment of malignant biliary obstruction (Bismuth type I or II)
2023, Surgical Endoscopy
The efficacy and safety of <sup>125</sup>I seeds combined with biliary stent placement versus stent placement alone for malignant biliary obstruction: a systematic review and meta-analysis
2023, Quantitative Imaging in Medicine and Surgery

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: None of the authors have identified a conflict of interest.

: A.H. and J.-P.G. contributed equally to this article.

View full text

Clinical StudyComparative Study of Percutaneous Transhepatic Biliary Stent Placement with or without Iodine-125 Seeds for Treating Patients with Malignant Biliary Obstruction

Abstract

Purpose

Materials and Methods

Results

Conclusions

Section snippets

Materials and Methods

Results

Discussion

Acknowledgments

Transplant Proc

Lancet

Semin Oncol

Lancet

Int J Radiat Oncol Biol Phys

Gastrointest Endosc

Gastrointest Endosc

J Hepatol

Review article: surgical, neo-adjuvant and adjuvant management strategies in biliary tract cancer

Aliment Pharmacol Ther

Cancer statistics, 2009

CA Cancer J Clin

Drug-eluting stent in malignant biliary obstruction

J Hepatobiliary Pancreat Surg

Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial

J Clin Oncol

Management of hilar biliary strictures

Am J Gastroenterol

Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline

Endoscopy

Role of chemotherapy in treatments for biliary tract cancer

J Hepatobiliary Pancreat Sci

A case of recurrent gastric cancer with obstructive jaundice successfully treated by docetaxel

Gan To Kagaku Ryoho

Immunological influence of iodine-125 implantation in patients with hepatocellular carcinoma resection

Nan Fang Yi Ke Da Xue Xue Bao

Clinical Study
Comparative Study of Percutaneous Transhepatic Biliary Stent Placement with or without Iodine-125 Seeds for Treating Patients with Malignant Biliary Obstruction