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Oral Iohexol in the Management of Chylous Ascites After After Retroperitoneal or Extended Lymphadenectomy

NCT06820320 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-06

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the effectiveness of oral iohexol in the treatment of postoperative chylous ascites. It will also learn about the safety of oral iohexol. The main questions it aims to answer are:

* Confirm the potential of oral iohexol as an innovative therapeutic regimen.
* Confirm its ability to improve clinical outcomes for patients.

Conditions

  • Chylous Ascites
  • Abdominal Neoplasm
  • Pelvic Neoplasms
  • Retroperitoneal Lymph Node Metastasis
  • Retroperitoneal Lymphadenectomy
  • Extended Lymphadenectomy

Interventions

DRUG

oral iohexol

Upon diagnosing chylous ascites, patients received oral iohexol treatment, a critical intervention in our therapeutic armamentarium. The initial oral dose was standardized to ensure a balance between efficacy and patient safety. In the event of a less than optimal response or significant drainage within the first 24 hours, a second identical dose of Iohexol was considered to maintain therapeutic concentration levels in the body.

PROCEDURE

Lymphangiography and Embolization

When conservative methods fall short in resolving chylous ascites, our protocol advances to precise interventional treatments. The escalation begins with ultrasound-guided lymphangiography. Through unilateral or bilateral inguinal lymph node access, iodized oil contrast is infused via a 9 ml/hour micro-pump, meticulously monitored by fluoroscopic imaging at 3-5 minutes intervals. Following precise localization of the leakage site, embolization is performed with a sequence of carefully calibrated steps. The process entails cone-beam CT scanning and 3D reconstruction for a clear depiction of the leak, followed by direct needle access to the lymphatic rupture under DSA guidance. A fine guidewire is inserted above the rupture, which facilitates the delivery of an embolizing mixture of iodized oil and NBCA glue. This is done with the utmost precision to prevent any spillage, ensuring the embolization's success and marking the conclusion of the procedure.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-15
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06820320 on ClinicalTrials.gov