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Cancer PatientsNCT07791719

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

A study testing Conventional Non-Tunneled PICC catheterization, One-Needle Tunneled PICC catheterization and Two-Needle Tunneled PICC catheterization in people with Cancer Patients, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cancer Patients
What is being tested?
Conventional Non-Tunneled PICC catheterization, One-Needle Tunneled PICC catheterization and Two-Needle Tunneled PICC catheterization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
801 participants
Where
1 siteChina
Study dates
10 Sep 2026to 30 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 75 years
  • Education level of primary school or above, with adequate reading, writing and --communication skills to independently complete the questionnaire
  • First-time PICC insertion using a 4Fr single-lumen solo PICC catheter
  • Able to attend follow-up visits at the same hospital for catheter maintenance after insertion
  • Willing to participate in the study and sign the informed consent form and PICC insertion consent form

Who cannot join

  • Coagulation dysfunction (INR > 1.5 or PLT < 25 × 10⁹/L)
  • Use of anticoagulants (e.g., warfarin, heparin) within 3 days before catheterization
  • Pregnant or lactating women
  • BMI < 18.5 kg/m²
  • Patients requiring lower extremity PICC insertion
  • Known or suspected allergy to components of the PICC catheter

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zeyin Hu contact

86+15899954190

huzy@sysucc.org.cn

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Jiasheng Huang, 86+17602023464, huangjs1@sysucc.org.cn

Other trials in China

About this study

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.

Read the detailed description

This study adopts a prospective, multicenter, three-arm, parallel-group randomized controlled design. A total of 801 patients will be recruited from 11 hospitals and randomly assigned in a 1:1:1 ratio to the three groups. The control group receives conventional non-tunneled PICC insertion. Experimental group 1 receives one-needle tunneled insertion (the needle travels subcutaneously for 4 cm before entering the vessel). Experimental group 2 receives two-needle tunneled insertion (with a 4 cm subcutaneous tunnel created using a tunneling tool). All insertions are performed by certified PICC nurses with over 5 years of experience who have received standardized training. The primary outcome is the overall incidence of catheter-related complications within 90 days post-insertion. Secondary outcomes include one-time puncture success rate, NRS pain score, intraoperative bleeding volume, catheterization time, and unplanned catheter removal rate. Outcome assessors and data analysts are blinded to group allocation. The study has been approved by the Ethics Committee of Sun Yat-sen University Cancer Center (Approval No. B2026-467-01, dated August 10, 2026).

Conditions
Cancer Patients
Being tested
Conventional Non-Tunneled PICC catheterization, One-Needle Tunneled PICC catheterization, Two-Needle Tunneled PICC catheterization
Keywords
Peripherally inserted central catheters ; tunneled; complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Non-Tunneled PICC catheterizationProcedure or surgery

    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.

  • One-Needle Tunneled PICC catheterizationProcedure or surgery

    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.

  • Two-Needle Tunneled PICC catheterizationProcedure or surgery

    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.

Study groups in NCT07791719
Study groupRoleWhat they receive
Conventional Non-Tunneled PICC catheterizationActive comparatorPatients receive conventional non-tunneled PICC insertion. The procedure involves ultrasound-guided vein puncture, guidewire insertion, local anesthesia and skin dilation, followed by sheath and catheter advancement. The catheter exit site is at the puncture site.
Receives: Procedure: Conventional Non-Tunneled PICC catheterization
One-Needle Tunneled PICC catheterizationExperimentalPatients receive one-needle tunneled PICC insertion. The puncture needle travels subcutaneously for 4 cm before entering the vessel, creating a subcutaneous tunnel. The skin puncture and catheter exit sites are the same. This technique requires only one needle pass for both tunneling and vessel puncture.
Receives: Procedure: One-Needle Tunneled PICC catheterization
Two-Needle Tunneled PICC catheterizationExperimentalPatients receive two-needle tunneled PICC insertion. Ultrasound-guided vein puncture is performed first, followed by creation of a 4 cm subcutaneous tunnel using a tunneling tool. The puncture site and catheter exit site are separate, with a subcutaneous tunnel connecting them.
Receives: Procedure: Two-Needle Tunneled PICC catheterization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Incidence of Catheter-Related Complications Within 90 Days Post-catheterization

    The composite endpoint includes: oozing/exudation at the catheter exit site, mechanical phlebitis, catheter-related bloodstream infection, local or tunnel infection, catheter-related thrombosis, catheter dislodgement or migration, catheter occlusion, contact dermatitis, and catheter breakage or damage. All complications are assessed from the day of insertion up to 90 days post-insertion.

    Measured: From catheterization to 90 days post-catheterization

Secondary outcomes (5)

  1. One-Time Puncture Success Rate

    Proportion of patients in whom the first puncture successfully enters the vein and the guidewire is smoothly advanced.

    Measured: Day 1 During catheterization procedure

  2. Pain Intensity During Catheterization (NRS Score)

    Pain level assessed using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) immediately after catheterization.

    Measured: Day 1 Immediately after catheterization procedure

  3. Intraoperative Bleeding Volume

    Total bleeding volume during catheterization, calculated by weighing gauze pads before and after the procedure (converted using whole blood specific gravity of 1.05 g/mL).

    Measured: Day 1 From start to end of catheterization procedure

  4. Catheterization Procedure Time

    Time from the first skin puncture to the moment the catheter is delivered to the predetermined length.

    Measured: Day 1 During catheterization procedure

  5. Unplanned Catheter Removal Rate

    Proportion of catheters removed prematurely due to complications (e.g., infection, thrombosis, dislodgement, occlusion) before the completion of treatment.

    Measured: From Day 1 catheterization to 90 days post-catheterization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start10 Sep 2026 (estimated)
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
801 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791719
Sponsor's protocol ID
Different PICC catheterization
Status last verified
Aug 2026
First submitted
25 Aug 2026
Last updated
28 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Non-Tunneled PICC catheterization, One-Needle Tunneled PICC catheterization and Two-Needle Tunneled PICC catheterization in people with Cancer Patients, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zeyin Hu (86+15899954190, huzy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Incidence of Catheter-Related Complications Within 90 Days Post-catheterization (time frame: From catheterization to 90 days post-catheterization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07791719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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