Clinical trial · Interventional
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
NCT06820320CI-TRIAL-00104868completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Neoplasm | — | UNRESOLVED | — |
| Chylous Ascites | — | UNRESOLVED | — |
| Extended Lymphadenectomy | — | UNRESOLVED | — |
| Pelvic Neoplasms | — | UNRESOLVED | — |
| Retroperitoneal Lymphadenectomy | — | UNRESOLVED | — |
| Retroperitoneal Lymph Node Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphangiography and Embolization | Procedure | — | UNRESOLVED |
| oral iohexol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- oral iohexol group
- interventionNames
- Drug: oral iohexol
- Procedure: Lymphangiography and Embolization
Primary outcomes (1)
- measure
- grading system for efficacy of iohexol intervention
- timeFrame
- up to 3 weeks after the intervention
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDGrist TM, Canon CL, Fishman EK, Kohi MP, Mossa-Basha M. Short-, Mid-, and Long-term Strategies to Manage the Shortage of Iohexol. Radiology. 2022 Aug;304(2):289-293. doi: 10.1148/radiol.221183. Epub 2022 May 19. PMID 35587228