## Protocol Section
### Identification Module
**NCT ID:** NCT01271179

**Brief Title:** Study of Sequential Perfusion of Liver Grafts to Prevent Nonanastomotic Biliary Strictures After Liver Transplantation

**Official Title:** Study of Sequential Perfusion of Liver Grafts With Low-viscosity and High-viscosity Preservation Solutions to Decrease the Incidence of Nonanastomotic Biliary Strictures After Liver Transplantation

#### Organization Study ID Info
**ID:** SFPH04618
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Jiao Tong University School of Medicine
### Status Module
#### Completion Date
**Date:** 2010-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-01-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-01-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-12

**Type:** ACTUAL

#### Start Date
**Date:** 2004-07

**Status Verified Date:** 2010-12

#### Study First Post Date
**Date:** 2011-01-06
**Type:** ESTIMATED
**Study First Submit Date:** 2010-12-30
**Study First Submit QC Date:** 2011-01-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shanghai Jiao Tong University School of Medicine

#### Responsible Party

**Old Name Title:** Zhi-Hai Peng/ vice-president of Shanghai First People's Hospital

**Old Organization:** Shanghai First People's Hospital

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The study was designed to investigate whether, compared with conventional sole perfusion with high-viscosity solution of University of Wisconsin (UW), sequential perfusion of liver grafts with low-viscosity and high-viscosity preservation solutions could further decrease the incidence of nonanastomotic biliary strictures (NAS) after liver transplantation.

**Detailed Description:** The exact etiology of nonanastomotic biliary strictures (NAS) with a patent hepatic artery after liver transplantation remains unclear so far. Microangiopathy is strongly suspected to be involved in the etiology, so sufficient flushing of peribiliary plexus (PBP) which directly nourishes the donor biliary tree may be pivotal to prevent NAS with a patent hepatic artery.

Solution of University of Wisconsin (UW solution) is a standard for liver graft flushing, but accused of high viscosity and hyperaggregation effect on erythrocytes by ingredient hydroxyethyl starch as well as initial vasoconstriction by high potassium content, which together constitutes a hindrance to solution penetration and thorough flushing of liver microcirculation including PBP. Several studies have revealed the relationship of high viscosity of UW solution with the development of NAS.

The investigators, therefore, have hypothesized that sequential perfusion with low-viscosity and high-viscosity preservation solutions might improve the patency of PBP in contrast with conventional sole perfusion with high-viscosity UW solution, and as a result, the incidence of NAS with a patent hepatic artery after liver transplantation would be significantly decreased.

### Conditions Module

**Conditions:**

- Liver Transplantation

- Transplant Recipient

**Keywords:**

- orthotopic liver transplantation

- preservation solution

- peribiliary plexus

- nonanastomotic biliary strictures

- primary non-function

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 141

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** sequential perfusion of liver grafts with low-viscosity improved Ross solution and high-viscosity UW solution.

**Intervention Names:**

- Procedure: sequential perfusion with ipv Ross solution and UW solution

**Label:** sequential perfusion

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** sole perfusion of liver grafts with high-viscosity UW solution only

**Intervention Names:**

- Procedure: sole perfusion with UW solution

**Label:** sole perfusion

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- sequential perfusion

**Description:** Totally 6 L of ipv Ross solution were initially infused (aortic: portal=1:1), followed by 2 L of cold UW solution infusion (aortic: portal=1:1).

**Name:** sequential perfusion with ipv Ross solution and UW solution

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- sole perfusion

**Description:** Totally 6 L of cold UW solution were infused (aortic: portal =1:1)

**Name:** sole perfusion with UW solution

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** PNF is defined as non-life-sustaining function of the graft unexplained by vascular complications or rejection, leading to death or retransplantation within postoperative 7 days.

**Measure:** Number of participants with primary non-function (PNF) for safety assessment of sequential perfusion

**Time Frame:** 1 week

**Description:** nonanastomotic biliary strictures secondary to hepatic arterial thrombosis or stenosis will be excluded from calculation.

**Measure:** Number of participants with nonanastomotic biliary strictures with a patent hepatic artery

**Time Frame:** 5 years

#### Secondary Outcomes

**Description:** IPF is defined as a delayed function restoration with serum AST level greater than 2,000 U/L and prothrombin time greater than 16 seconds postoperative days 2 to 7.

**Measure:** Number of participants with initial poor function (IPF)

**Time Frame:** 1 week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age≥18 years
* ability to provide written informed consent prior to study entry
* receiving a whole liver graft
* primary transplantation

Exclusion Criteria:

* participant in other clinical trials
* fulminant liver failure as the cause of transplantation
* primary biliary cirrhosis, autoimmune hepatitis or primary sclerosing cholangitis as primary liver disease
* retransplantation
* non-liver organ(s) failure prior to study entry
* donor/recipient ABO-blood-group-incompatibility

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shanghai

**Country:** China

**Facility:** Shanghai First People's Hospital

**State:** Shanghai

**Zip:** 200080

#### Overall Officials

**Official 1:**

**Affiliation:** Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

**Name:** Zhi-Hai Peng, Prof.

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Moench C, Moench K, Lohse AW, Thies J, Otto G. Prevention of ischemic-type biliary lesions by arterial back-table pressure perfusion. Liver Transpl. 2003 Mar;9(3):285-9. doi: 10.1053/jlts.2003.50015.

**PMID:** 12619026

**Citation:** Pirenne J, Van Gelder F, Coosemans W, Aerts R, Gunson B, Koshiba T, Fourneau I, Mirza D, Van Steenbergen W, Fevery J, Nevens F, McMaster P. Type of donor aortic preservation solution and not cold ischemia time is a major determinant of biliary strictures after liver transplantation. Liver Transpl. 2001 Jun;7(6):540-5. doi: 10.1053/jlts.2001.24641.

**PMID:** 11443584

**Citation:** Sanchez-Urdazpal L, Gores GJ, Ward EM, Maus TP, Buckel EG, Steers JL, Wiesner RH, Krom RA. Diagnostic features and clinical outcome of ischemic-type biliary complications after liver transplantation. Hepatology. 1993 Apr;17(4):605-9. doi: 10.1002/hep.1840170413.

**PMID:** 8477965

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### 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: HIGH

- As Found: Stricture

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003251

- Term: Constriction, Pathologic

### Intervention Browse Module - Ancestors

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000014665

- Term: Vasodilator Agents

- ID: D000058906

- Term: Purinergic P1 Receptor Agonists

- ID: D000058913

- Term: Purinergic Agonists

- ID: D000058905

- Term: Purinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000963

- Term: Antimetabolites

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000006074

- Term: Gout Suppressants

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000016166

- Term: Free Radical Scavengers

- ID: D000000975

- Term: Antioxidants

- ID: D000020011

- Term: Protective Agents

- ID: D000007004

- Term: Hypoglycemic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: HIGH

- As Found: Procedure

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M10365

- Name: Insulin

- Relevance: HIGH

- As Found: Juvenile-onset

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M3834

- Name: Allopurinol

- Relevance: HIGH

- As Found: Juvenile-onset

- ID: M3595

- Name: Adenosine

- Relevance: HIGH

- As Found: Juvenile-onset

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007328

- Term: Insulin

- ID: D000000493

- Term: Allopurinol

- ID: D000000241

- Term: Adenosine

- ID: D000019999

- Term: Pharmaceutical Solutions

### Misc Info Module

- Version Holder: 2024-05-24
