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

Phase 2

Not yet recruiting

• Conditions: Retroperitoneal Lymph Node Metastasis; Extended Lymphadenectomy; Chylous Ascites; Abdominal Neoplasm; Pelvic Neoplasms; Retroperitoneal Lymphadenectomy
• Interventions: Drug: oral iohexol; Procedure: Lymphangiography and Embolization

• Registration Number: NCT06820320
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-02-08
• Last Update Submitted: 2025-02-08
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-02-15
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients between the ages of 18 and 75 years;
• Patients underwent retroperitoneal or extended lymphadenectomy for abdominal or pelvic malignant tumors;
• Patients diagnosisted with postoperative Chylous ascites. Chylous ascites were defined by the presence of non-infectious, milky, or creamy effluent in drainage tubes surpassing 200 mL daily, paired with triglyceride concentrations exceeding 110 mg/dL

Exclusion Criteria

• Patients with severe cardiac, hepatic and renal insufficiency;
• Patients with a history of iohexol allergy or allergy to contrast media;
• Patients who have received other interventions;
• Patients with severe intestinal obstruction or intestinal perforation;
• Patients who are unable to comply with the requirements of the study or are unable to complete follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
oral iohexol group	oral iohexol	-
oral iohexol group	Lymphangiography and Embolization	-

Primary Outcome Measures

Name	Time	Method
grading system for efficacy of iohexol intervention	up to 3 weeks after the intervention	The clinical responses post-Iohexol administration were evaluated against a set grading system:Grade A Success: This grade was assigned to patients who achieved complete cessation of lymphatic drainage with no clinical evidence of chylous ascites by the end of the first week post-treatment. To further ascertain the rapid action of Iohexol, 'Grade A+ Success' was defined for scenarios where this resolution occurred within the initial 3 days post-intervention. Grade B Success: Representing a substantial but partial therapeutic response, Grade B was denoted for patients who exhibited more than a 50% reduction in baseline lymphatic drainage within the first week, but did not meet the criteria for Grade A success. Non-responders: Patients who did not conform to the criteria for Grade A or B success were categorized as non-responders. This group was identified for further evaluation and considered for additional treatment modalities.

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China