Diagnostic lymphangiography with therapeuticeffect: Since more than 70 years Lipiodol is used asan off-label standard of care for chylothorax -why not convert to on-label use?

Mosler, Frank; Mertineit, Nando; Kampmann, Manuel; Nöldge, Gerd (2023). Diagnostic lymphangiography with therapeuticeffect: Since more than 70 years Lipiodol is used asan off-label standard of care for chylothorax -why not convert to on-label use? Swiss journal of radiology and nuclear medicine, 1(1), pp. 2-11. GMC precision GmbH 10.59667/sjoranm.v1i.14

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Purpose: The use of Lipiodol as a diagnostic agent and off-label therapeutic agent has been investigated in well over 395 publications listed in Pubmed under the key words: lymphangiography and chylothorax in the time period between 1921-2021.
While Lipiodol® ultra-fluid has been approved for use as a diagnostic agent in most countries, it can only be used off-label as a therapeutic agent for chylothorax, cholascos, and lymphatic leaks and fistulas. The therapeutic effects in chylothorax and the question why Lipiodol® ultra-fluid is still not approved for on-label use in the treatment of chylothorax are reviewed.
Background: Lipiodol was synthesized as iodized poppy seed oil by the French pharmacist Marcel Guerbet and first described by him in 1901. Over the past 12 decades, it has proven to be a reliable and versatile clinical theranostic agent. Lipiodol® ultra-fluid has been used (a) as a diagnostic contrast agent alone in the clarification and (b) so far only in off-label use as a therapeutic agent for chylothorax or cholascos, e.g. in cases of postoperative lymph leakages. Lipiodol® ultra-fluid has, to our knowledge, only very limited approvals as a therapeutic agent, in Switzerland only for transarterial chemoembolization (TACE) of liver cancer.
For decades and in numerous countries, Lipiodol® ultra-fluid has been in use as first-line treatment of chylothorax, cholascos, lymphatic leakage or lymphatic fistulae, avoiding additional interventions or surgery.
This review aims to assess in which countries Lipiodol® ultra-fluid is approved (a) as a primary diagnostic tool and (b) as a first line therapeutic agent. This review wants to reassess why the general therapeutic approval still lacks, and what could be done to achieve it.

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