Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial

Summary

This study aims to compare the clinical effectiveness of three PICC (Peripherally Inserted Central Catheter) insertion methods: conventional non-tunneled PICC, one-needle tunneled PICC, and two-needle tunneled PICC. This is a multicenter randomized controlled trial involving 11 hospitals in China, with a total of 801 patients scheduled to undergo PICC insertion for the first time. Patients will be randomly assigned in a 1:1:1 ratio to the three groups. The primary outcome is the incidence of post-insertion complications (including oozing, infection, thrombosis, catheter dislodgement, etc.) within 90 days. Secondary outcomes include one-time puncture success rate, pain level (NRS), bleeding volume, catheterization time, and unplanned catheter removal rate. The results will provide evidence for selecting the optimal PICC insertion method in clinical practice.

Conditions

• Cancer Patients

Interventions

PROCEDURE

Conventional Non-Tunneled PICC catheterization

Ultrasound-guided vein puncture, followed by guidewire insertion, local anesthesia, skin dilation, sheath advancement, and catheter delivery. The catheter exit site is at the puncture site with no subcutaneous tunnel created.

PROCEDURE

One-Needle Tunneled PICC catheterization

The puncture needle travels subcutaneously for 4 cm before entering the vessel, creating a subcutaneous tunnel with a single needle pass. The puncture site and catheter exit site are the same. This technique combines tunneling and vessel puncture in one step.

PROCEDURE

Two-Needle Tunneled PICC catheterization

A two-step procedure: first, ultrasound-guided vein puncture is performed; then, a separate subcutaneous tunnel of 4 cm is created using a tunneling tool. The puncture site and catheter exit site are separate, connected by a subcutaneous tunnel. The catheter is pulled through the tunnel from the exit site to the puncture site.

Sponsors & Collaborators

• Gansu Hospital of Sun Yat-sen University Cancer Center

  collaborator UNKNOWN

• Shenzhen People's Hospital

  collaborator OTHER

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• Haikou People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Jiangsu Cancer Institute & Hospital

  collaborator OTHER

• Wuzhou Red Cross Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Jieyang People's Hospital

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-10

Primary Completion

2027-05-30

Completion

2027-08-30

Countries

• China

Study Locations