Association Between Irrigation Fluid Absorption and Perioperative cfDNA Dynamics After TURBT

A Predictive Model for Recurrence and Progression Risk After TURBT for Bladder Cancer on Intraoperative Irrigation Fluid Absorption Volume and Perioperative cfDNA Levels

This prospective observational cohort study aims to evaluate the association between intraoperative irrigation fluid absorption and perioperative cell-free DNA (cfDNA) dynamics in patients undergoing transurethral resection of bladder tumor (TURBT). Eligible patients with suspected or confirmed bladder cancer scheduled for TURBT will be enrolled. Intraoperative irrigation fluid absorption volume will be recorded, and peripheral blood samples will be collected before surgery and within 24 hours after surgery for cfDNA extraction and mutation analysis.

The study will assess whether irrigation fluid absorption volume is associated with changes in cfDNA concentration, tumor-related mutation detection, and clinicopathological features, including tumor stage, grade, size, number, invasion depth, concomitant carcinoma in situ, operative time, resection depth, and intraoperative blood loss. Patients will also be followed for postoperative recurrence, progression, metastasis, and other adverse oncological outcomes.

This study may provide preliminary evidence for understanding perioperative tumor-related molecular changes during TURBT and may help improve risk stratification, perioperative management, and postoperative follow-up strategies for patients with bladder cancer.

Study Overview

• Status: Recruiting
• Conditions: Urothelial Carcinoma of the Bladder; Bladder (Urothelial, Transitional Cell) Cancer; Bladder Cancer Recurrence; Progression of Bladder Cancer; Transurethral Resection of Bladder Tumor
• Intervention / Treatment: Other: Measurement of Intraoperative Irrigation Fluid Absorption and Perioperative cfDNA Profiling

Detailed Description

Bladder cancer is one of the most common malignancies of the urinary system. Non-muscle-invasive bladder cancer accounts for the majority of newly diagnosed cases. Transurethral resection of bladder tumor (TURBT) is the standard procedure for the diagnosis, staging, and initial treatment of bladder cancer, particularly non-muscle-invasive bladder cancer. However, postoperative recurrence and progression remain common in some patients, especially those with high-risk pathological features.

During TURBT, mechanical resection, electrosurgical thermal injury, and continuous bladder irrigation may lead to tumor cell shedding and the release of tumor-derived molecular components into the irrigation fluid. Disruption of the mucosal and vascular barriers, opening of venous sinuses, increased intravesical pressure, and absorption of irrigation fluid may theoretically facilitate the entry of tumor-related components into the circulation. Although previous studies have mainly focused on intravesical tumor cell implantation and local recurrence, the relationship between intraoperative irrigation fluid absorption, perioperative cfDNA dynamics, and postoperative oncological outcomes remains insufficiently understood.

In this prospective observational cohort study, patients undergoing TURBT for suspected or confirmed bladder cancer will be enrolled. Intraoperative irrigation fluid absorption volume will be measured and recorded. Peripheral blood samples will be collected before surgery and within 24 hours after surgery for cfDNA extraction and mutation analysis using a multiplex mutation detection system based on nucleic acid mass spectrometry. Tumor tissue mutation status will also be evaluated when available.

The primary objective is to determine whether the volume of intraoperative irrigation fluid absorption is associated with perioperative changes in plasma cfDNA levels and tumor-related mutation detection. Secondary objectives include evaluating the association of cfDNA dynamics and irrigation fluid absorption with clinicopathological characteristics, including tumor stage, grade, size, number, invasion depth, concomitant carcinoma in situ, operative time, resection depth, and blood loss. Postoperative recurrence, progression, metastasis, and other adverse oncological outcomes will be assessed during follow-up.

The study is observational and will not alter standard clinical treatment decisions. The findings may help clarify perioperative molecular changes associated with TURBT and provide preliminary evidence for improving risk stratification and individualized postoperative surveillance in patients with bladder cancer.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Recruiting
      • The Second Hospital of Lanzhou University
      • Contact: Hongqin Zhao, Master of Medicine; Phone Number: +86 13830170665; Email: 1372389220@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include adults aged 18 years or older with suspected or confirmed bladder urothelial carcinoma who are scheduled to undergo TURBT at the Second Hospital of Lanzhou University. Eligible participants must be able to provide sufficient peripheral blood samples for cfDNA extraction and mutation analysis. Postoperative pathological diagnosis will be used to confirm eligibility for the final analysis when applicable. Patients will receive standard clinical management, and participation in this observational study will not affect treatment decisions.

Description

Inclusion Criteria:

1. Age 18 years or older.
2. Suspected or histologically confirmed urothelial carcinoma of the bladder.
3. Scheduled to undergo TURBT.
4. Availability of sufficient peripheral blood samples for cfDNA extraction and mutation analysis.
5. Availability of complete clinicopathological and perioperative data.
6. Ability to provide informed consent and comply with study follow-up.

Exclusion Criteria:

1. Non-urothelial bladder malignancy confirmed by pathology.
2. History of other malignant tumors within the past 5 years, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
3. Previous radical cystectomy or systemic antitumor therapy before enrollment.
4. Inadequate blood sample quality or insufficient DNA yield for mutation analysis.
5. Pregnancy or breastfeeding.
6. Serious uncontrolled intercurrent illness that may interfere with study participation, follow-up, or compliance, including active infection, symptomatic congestive heart failure, unstable angina, clinically significant arrhythmia, severe psychiatric illness, or other conditions judged by the investigator to make participation unsuitable.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients Undergoing TURBT for Bladder Cancer; Adult patients with suspected or confirmed bladder urothelial carcinoma who are scheduled to undergo TURBT will be enrolled. Intraoperative irrigation fluid absorption volume, perioperative plasma cfDNA levels, mutation status, clinicopathological features, and postoperative oncological outcomes will be collected and analyzed.

Other: Measurement of Intraoperative Irrigation Fluid Absorption and Perioperative cfDNA Profiling; This is an observational exposure assessment. Intraoperative irrigation fluid absorption volume will be recorded during TURBT using a dedicated measurement system. Peripheral blood samples will be collected before surgery and within 24 hours after surgery for cfDNA extraction and mutation analysis. Tumor tissue mutation status will be assessed when available. No active therapeutic intervention, treatment modification, or change in clinical decision-making will be performed as part of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plasma cfDNA Level From Before TURBT to Within 24 Hours After TURBT	The primary outcome is the perioperative change in plasma cfDNA level, calculated by comparing cfDNA concentration before TURBT and within 24 hours after TURBT. The association between intraoperative irrigation fluid absorption volume and cfDNA change will be evaluated.	From preoperative blood collection to within 24 hours after TURBT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection Rate of Tumor-Related Mutations in Perioperative cfDNA	The detection rate of bladder cancer-related mutations in plasma cfDNA before and after TURBT will be assessed using a multiplex mutation detection system based on nucleic acid mass spectrometry.	From preoperative blood collection to within 24 hours after TURBT

Collaborators and Investigators

• Sponsor: Zhiping Wang
• Investigators: Principal Investigator: Zhiping Wang, Lanzhou University Second Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 9, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: bladder cancer; recurrence; urothelial carcinoma; cell-free DNA; progression; circulating tumor DNA; TURBT; mutation profiling; nucleic acid mass spectrometry; irrigation fluid absorption
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Neoplasms; Recurrence; Disease Progression; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
• Other Study ID Numbers: LZU2H-BCa-Rinse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The possibility of sharing de-identified individual participant data will be evaluated after study completion. Any future data sharing will depend on the scope of informed consent, institutional policies, ethics approval requirements, and the establishment of appropriate data use agreements. Shared data, if available, will not contain personally identifiable information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No