Comparison of Two Seed Strand Implantation Techniques for Biliary Cancer

NCT07381439 | Completed

• 1 other identifier: LLSC20221301
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the safety and effectiveness of two different methods for fabricating and implanting Iodine-125 (\^125\^I) radioactive seed strands combined with a metal stent for treating malignant obstructive jaundice. The conventional method uses a straight seed strand placed between the stent and the bile duct wall. A novel technique was developed that uses a spiral-shaped seed strand placed inside the stent lumen. Between January 2018 and February 2024, 105 patients were randomly assigned to two groups. Group A (59 patients) received the conventional straight strand, while Group B (46 patients) received the novel spiral strand. The study compared therapeutic efficacy, the incidence of intraoperative and postoperative complications, stent patency duration, and patient survival. Both methods successfully improved liver function. However, the novel spiral technique (Group B) caused significantly fewer complications, such as bile leakage and peritonitis, compared to the conventional method (Group A). Importantly, patients in Group B also had longer stent patency (305 days vs. 277 days) and longer overall survival (345 days vs. 300 days). In conclusion, the novel spiral seed strand implantation technique is a safer and more effective treatment option for malignant obstructive jaundice.

Conditions

Malignant Obstructive Jaundice

Keywords

Malignant obstructive jaundice; 125I seeds strand; Complications

Outcome Measures

Primary Outcomes (2)

• Stent Patency Time

  The duration from the date of stent placement to the date of first documented stent re-obstruction (confirmed by imaging evidence of restenosis or occlusion). For patients who die without prior evidence of recurrent jaundice, the data will be censored at the date of death.

  From the date of randomization/stent placement until the date of documented stent re-obstruction or death from any cause, whichever occurs first, assessed up to 24 months.

• Overall Survival

  The time from the date of the stent placement procedure until the date of death from any cause. For patients who are alive at the end of the study, survival data will be censored at the date of the last follow-up contact.

  From the date of randomization/stent placement until the date of death from any cause, assessed up to 24 months.

Secondary Outcomes (5)

• Incidence of Procedure-Related Complications

  Intraoperative period and up to 30 days after the procedure.

• Change in Serum Total Bilirubin (TBIL) Level

  Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.

• Change in Serum Alanine Aminotransferase (ALT) Level

  Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.

• Change in Serum Aspartate Aminotransferase (AST) Level

  Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.

• Technical Success Rate

  Assessed immediately upon completion of the stent and seed strand implantation procedure.

Study Arms (2)

Conventional linear implantation

EXPERIMENTAL

In this group, participants received percutaneous transhepatic biliary stenting combined with a straight-configured \^125\^I seed strand. The strand was fabricated by loading the prescribed number of \^125\^I seeds into a 4F catheter, the ends of which were subsequently heat-sealed. During the procedure, after the deployment of a self-expanding metallic stent across the malignant stricture, the straight seed strand was implanted and fixed in the space between the outer wall of the stent and the bile duct wall to deliver localized brachytherapy.

Radiation: Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strand

Novel spiral implantation

EXPERIMENTAL

In this group, participants received percutaneous transhepatic biliary stenting combined with a spiral-configured \^125\^I seed strand. The strand was fabricated by first preparing a linear catheter strand and then shaping it into a spiral configuration using boiling water. A slightly higher number of seeds were used to compensate for foreshortening. During the procedure, after stent deployment, the spiral seed strand was implanted and secured within the inner lumen of the metallic stent. This method was designed to reduce tract-related injury by utilizing a single, smaller working sheath and minimizing manipulation of the bile duct wall.

Radiation: Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strand

Interventions

Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strand RADIATION

This is a combined interventional radiology procedure for malignant obstructive jaundice. Under local anesthesia and fluoroscopic guidance, a self-expanding metallic biliary stent is percutaneously placed across the malignant stricture. Subsequently, a spiral-configured strand of Iodine-125 (\^125\^I) seeds, fabricated by shaping a linear catheter strand with boiling water (using a slightly higher seed count to compensate for foreshortening), is implanted and secured within the inner lumen of the stent. The \^125\^I seeds provide continuous low-dose-rate brachytherapy to inhibit tumor ingrowth and prolong stent patency. This method is designed to reduce tract-related injury by minimizing bile duct wall manipulation.

Also known as: PTBSIS (novel)

Novel spiral implantation

Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strand RADIATION

This is a combined interventional radiology procedure for malignant obstructive jaundice. Under local anesthesia and fluoroscopic guidance, a self-expanding metallic biliary stent is percutaneously placed across the malignant stricture. Subsequently, a linear strand of Iodine-125 (\^125\^I) seeds, fabricated by sealing the prescribed number of seeds within a catheter, is implanted and fixed in the space between the outer wall of the stent and the bile duct wall. The \^125\^I seeds provide continuous low-dose-rate brachytherapy to inhibit tumor ingrowth and prolong stent patency.

Also known as: PTBSIS

Conventional linear implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with a definitive diagnosis of Malignant Obstructive Jaundice (MOJ) confirmed by imaging (enhanced CT/MRCP), laboratory tests, and/or pathology.
• \. Assessed by a multidisciplinary team as not a candidate for curative surgical resection.
• \. No absolute contraindications for the combined implantation of a biliary metallic stent and an \^125\^I seeds strand (e.g., severe coagulation dysfunction, significant renal impairment, or uncontrolled serious cardiovascular/cerebrovascular diseases).
• \. Willing and able to provide written informed consent.

You may not qualify if:

• Obstructive jaundice attributable to benign etiology.
• Life expectancy estimated to be less than three months.
• Unwillingness to participate in the study or provide informed consent.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

Related Publications (3)

• Wang W, Shen J, Wang C, Ren B, Zhu X, Ni C. Safety and Feasibility of Helical I-125 Seed Implants Combined with Transcatheter Arterial Chemoembolization in Hepatocellular Carcinomas with Main Portal Vein Tumor Thrombus. Cardiovasc Intervent Radiol. 2019 Oct;42(10):1420-1428. doi: 10.1007/s00270-019-02256-z. Epub 2019 Jun 11.

  PMID: 31187228 RESULT

• Jang S, Stevens T, Parsi MA, Bhatt A, Kichler A, Vargo JJ. Superiority of Self-Expandable Metallic Stents Over Plastic Stents in Treatment of Malignant Distal Biliary Strictures. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e182-e195. doi: 10.1016/j.cgh.2020.12.020. Epub 2020 Dec 18.

  PMID: 33346140 RESULT

• Larghi A, Tringali A, Lecca PG, Giordano M, Costamagna G. Management of hilar biliary strictures. Am J Gastroenterol. 2008 Feb;103(2):458-73. doi: 10.1111/j.1572-0241.2007.01645.x. Epub 2007 Nov 19.

  PMID: 18028506 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Model Details: This is a two-arm, parallel-group, randomized controlled trial comparing a novel spiral seed strand implantation technique with the conventional linear technique.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 2, 2026
• Study Start: January 1, 2018
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)