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The tumor registry treats patients and their ablated lesions somewhat separately. Some conclusions are drawn "per patient" e.g.. hospitalization time whereas other parameters are related to every single lesion. To clarify the distinction between patient and lesion all sheets have either a patient or lesion logo.
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We collect information on the number of tumors per patient, the
histology, the pre-ablation size, the location (using segmental
anatomy of the liver), the ablation parameters and CT follow-up
of the lesions. It may be helpful to have the "Patient Demographics"
and "Individual Lesion" data sheets with you in the OR to facilitate
data collection.
The forms may be useful in your own on site record keeping. Once your
center has a series of patients, in the database you may also obtain
summary information on your cases on our web site.
All patient information will be kept in the strictest confidence, and
the database link to the web site will be secured to allow access to
summary information only to physicians participating in the data
collection.
The proposed time points for CT scans and laboratory studies are
On post op day 1 the "routine patient" at our institution has
blood drawn but not a CT scan.
We created sheets to be used during the operation, for immediate postoperative data collection and for long-term follow up. Because surgery and the postoperative examination are only a week apart, you might send both sheets together after the postoperative examination.
The quarterly long-term follow up sheets are identical, so please don't forget to indicate the month of follow up. If follow up data is greater than one month overdue, we will send a reminder by e-mail.
All sheets are designed to be intuitive, understandable and easy to fill out. We have tried to reduce the questions to a minimum and therefore all fields are mandatory information and should be filled out!
A more extensive study is planned for the near future. It may include liver function data and hematologic parameters . Your input is welcome in designing the extended study.
Definition of terms used in the registry
Most of the fields are self explanatory, however as with everything it is important to insure that we are speaking the same "language". The following glossary of terms may help.
successful ablation: the apparent size of the lesion as measured in the CT (MRI) scans is larger on the first postoperative (1 week) scan indicating that the ablative process encompassed the entire lesion as well as a rim of surrounding normal liver tissue as a margin. Thereafter the size of the lesion should progressively decrease on each quarterly scan.
ablation failure or local recurrence: a clear indication on the initial CT (MRI) scan that the lesion was not encompassed by the ablation process (no increase in size or clearly perfused areas within the lesion). On the quarterly follow-up scans any increase in size or the appearance of perfused tumor at any of the margins of the lesion indicates a local recurrence.
Ablation failures are subdivided into
definite recurrence: there is a unequivocal local regrowth of a previously ablated lesion.
suspect recurrence: the patient who develops multifocal disease within the liver and any of the new foci are adjascent to a zone of ablation
Many patients have recurrence or the appearance of new disease that is amenable to repeat treatment. If a patient is retreated it should be handled the same as a new patient. This means that you will generate a new operative data sheet and new immediate postoperative and quarterly follow up sheets using the new treatment date as the reference date. If there is a clear distinction of the new lesions treated and the old you may continue to enter data for both ablations. However if the distinction is unclear you should follow the new lesions and close out the data from the original ablation by referring it to the new date.
Download the registry instructions as pdf-file
