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Figure 2. Radiology pathway for the patients in service evaluation protocol.

OUTCOME MEASURES AND DATA MANAGEMENT
The FTWG and LAG recognised the importance of having a set of triggers in the interim period till the
service evaluation is completed. These triggers are to take stock of unexpected events and advise LAG and
individual centres of necessary action points. These triggers may also mandate a re-evaluation of the
protocol agreed upon by the FTWG.

The implementation group recommends analysis of the perioperative and cancer specific outcomes after
recruitment and completion of treatment for 30 patients, including both iCCA and pCCA.

As the numbers are small, it was felt that trigger points should be based on events rather than percentage
occurrence. The group agreed to label these as “adverse events of special interest”, which will include
vascular thrombosis within 3 months, recurrent cancer within 6 months, cancer-related mortality within 12
months, and re-transplantation for any reason.

The group recommended that such events should be discussed with the NERP to facilitate improvements in
outcomes rather than imposing a moratorium.

A moratorium will only be advised if the events are felt to be repetitive with a clear pattern behind the
failures.

In cases where the waiting list outcomes demonstrate a high rate of dropouts or significant delays in
transplant patients, the process of offering donors may be reviewed and revised accordingly.