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

NCT ID: NCT06820320

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2026-11-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

oral iohexol group

Group Type: EXPERIMENTAL

oral iohexol

Intervention Type: DRUG

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.

Lymphangiography and Embolization

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jianwei Liang, Doctor of Medicine

Role: CONTACT

liangjianwei@outlook.com

86-01087787110

References

Grist 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.

Reference Type: BACKGROUND

PMID: 35587228 (View on PubMed)

Other Identifiers

No, 24/368-4648

Identifier Type: -

Identifier Source: org_study_id