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

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.

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Key information

Conditions

Chylous Ascites Abdominal Neoplasm Abdominal Neoplasms Digestive System Diseases Extended Lymphadenectomy Neoplasms Neoplasms by Site Pelvic Neoplasms Peritoneal Diseases Retroperitoneal Lymph Node Metastasis Retroperitoneal Lymphadenectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral iohexol

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

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.

Primary outcomes

grading system for efficacy of iohexol intervention

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 11, 2025
Registry last updated: Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed