NCT06820320

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

Oral Iohexol in the Management of Chylous Ascites After Retroperitoneal or Extended Lymphadenectomy for Abdominal or Pelvic Malignant Tumor: An Innovative and Convenient Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-02-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-02-11
• Last updated: 2026-03-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study