## Protocol Section
### Identification Module
**NCT ID:** NCT02001779

**Acronym:** IRCSMBO

**Brief Title:** IRS(Irradiation Stent) vs. CS(Conventional Stent) Insertion in Inoperable Malignant Biliary Obstruction

**Official Title:** Study of Stent Insertion Combined With or Without Brachytherapy in Patients With Inoperable Malignant Biliary Obstruction

#### Organization Study ID Info
**ID:** IR-C-STENT-MBO-83272121
#### Organization
**Class:** OTHER
**Full Name:** Zhongda Hospital
### Status Module
#### Completion Date
**Date:** 2016-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-14

**Type:** ACTUAL

**Last Update Submit Date:** 2017-02-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-09

**Type:** ACTUAL

#### Start Date
**Date:** 2013-10

**Type:** ACTUAL

**Status Verified Date:** 2017-02

#### Study First Post Date
**Date:** 2013-12-05
**Type:** ESTIMATED
**Study First Submit Date:** 2013-11-22
**Study First Submit QC Date:** 2013-12-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhongda Hospital

#### Responsible Party

**Investigator Affiliation:** Zhongda Hospital

**Investigator Full Name:** Gao-jun Teng

**Investigator Title:** Professor of Radiology & Chair,Department of Radiology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Stenting the malignant biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated the safety and technical feasibility of an irradiation biliary stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.

**Detailed Description:** Malignant biliary obstruction is a common condition caused by various carcinomas.The clinical process is usually silent and insidious,only 10-20% patients can be surgically removed once obstructive jaundice occurred.The long-term survival rate after resection remain dismal.Relief of obstructive jaundice plays major role on prognosis in patients without surgical indications.For unresectable patients,stenting the biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice.Although a number of new techniques for treatment of malignant biliary obstruction have been developed,there have been no significant differences in survival or quality of life comparing surgery bypass versus plastic stent insertion,metal stent insertion versus plastic stents insertion,or covered stent versus uncovered stents insertion in such patients.Our previous unicentric clinical trial has demonstrated the safety and technical feasibility of a biliary intraluminal irradiation stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion in the overall survival and stent patency between two groups.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.

### Conditions Module

**Conditions:**

- Malignant Biliary Obstruction

**Keywords:**

- Malignant biliary obstruction

- Obstruction/stricture

- Stent

- Brachytherapy

- Bile duct

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 328

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction.

**Intervention Names:**

- Device: Biliary SEMS loaded with 125I seeds

**Label:** Biliary SEMS loaded with 125I seeds

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A self-expandable metallic biliary stent is inserted in patients with inoperable malignant biliary obstruction.

**Intervention Names:**

- Device: Conventional biliary SEMS

**Label:** Conventional biliary SEMS

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Biliary SEMS loaded with 125I seeds

**Description:** A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction.

**Name:** Biliary SEMS loaded with 125I seeds

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Conventional biliary SEMS

**Description:** A self-expandable metallic stent is inserted in patients with inoperable malignant biliary obstruction.

**Name:** Conventional biliary SEMS

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Time from stenting to the day when stricture/obstruction of the stent occured or restricture/reobstruction after recanalization the obstructed stent.

**Measure:** Patency

**Time Frame:** Participants will be followed till die or lost to follow-up,an expected average of a year.

#### Secondary Outcomes

**Description:** Time from stenting to the day when the patients died or lost to the follow-up.

**Measure:** Over survival

**Time Frame:** Participants will be followed till die or lost to follow-up,an expected average of a year.

**Description:** The rate of relief of the symptoms and signs of the patients.

**Measure:** Clinical success

**Time Frame:** Participants will be followed till die or lost to follow-up,an expected average of a year.

**Description:** Including technique success rate,side effect/complication,radioactive safety.

**Measure:** Safety

**Time Frame:** Participants will be followed till die or lost to follow-up,an expected average of a year.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Clinical,histological or pathological diagnosis of malignant biliary obstruction
* Unresectability or refusal to be surgically treated
* The Eastern Cooperative Oncology Group(ECOG) scores from 0 to 3
* With symptoms such as jaundice related to biliary obstruction
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Biliary obstruction of Bismuthe-Corlette,type I and II

Exclusion Criteria:

* Benign biliary obstruction
* The Eastern Cooperative Oncology Group(ECOG) score of 4
* Biliary tract stricture that could not be dilated enough to pass the delivery system
* Presence of metallic biliary stent or bile duct surgery
* Percutaneous transhepatic cholangiography(PTC) procedure was contraindicated
* Active hepatitis
* Biliary obstruction of Bismuthe-Corlette,type Ⅲ and Ⅳ
* Uncooperative or could not provide authorization and signature

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nanjing

**Country:** China

**Facility:** Zhongda Hospital,Southeast University

**State:** Jiangsu

**Zip:** 210009

#### Overall Officials

**Official 1:**

**Affiliation:** Zhongda Hospital

**Name:** Gao-jun Teng, Ph.D,MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Zhu HD, Guo JH, Huang M, Ji JS, Xu H, Lu J, Li HL, Wang WH, Li YL, Ni CF, Shi HB, Xiao EH, Lv WF, Sun JH, Xu K, Han GH, Du LA, Ren WX, Li MQ, Mao AW, Xiang H, Zhang KX, Min J, Zhu GY, Su C, Chen L, Teng GJ. Irradiation stents vs. conventional metal stents for unresectable malignant biliary obstruction: A multicenter trial. J Hepatol. 2018 May;68(5):970-977. doi: 10.1016/j.jhep.2017.12.028. Epub 2018 Jan 10.

**PMID:** 29331343

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10488

- Name: Iodine

- Relevance: LOW

- As Found: Unknown

- ID: M229695

- Name: Cadexomer iodine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
