NCT06850753: SURE-LT

En Bloc Resection of the Liver and Pancreas With a "Non-touch" Technique Followed by Liver Transplantation to Improve the Overall Survival in Patients With Non-resectable Hilar Cholangiocarcinoma Beyond the Mayo Clinic Transplant Criteria

Recruiting now NA Last updated 21 August 2025

What this trial tests

NA trial testing Liver transplantation after en bloc resection of the liver and pancreas in Cholangiocarcinoma Non-resectable in 15 participants. Currently enrolling.

Timeline

1 January 2025

Primary endpoint
31 December 2030

31 December 2030

Quick facts

Lead sponsor	Oslo University Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 January 2025
Primary completion	31 December 2030
Estimated completion	31 December 2030
Sites	1 location across Norway

Drugs / interventions tested

• Liver transplantation after en bloc resection of the liver and pancreas

Conditions studied

• Cholangiocarcinoma Non-resectable — all drugs for Cholangiocarcinoma Non-resectable →
• Cholangiocarcinoma Recurrent — all drugs for Cholangiocarcinoma Recurrent →
• Liver Transplantation — all drugs for Liver Transplantation →

Sponsor

Oslo University Hospital

Who can join

Adults 18 to 70, any sex, with Cholangiocarcinoma Non-resectable or Cholangiocarcinoma Recurrent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Surgery for hilar cholangiocarcinoma (phCCA) remains a significant challenge. The minority of patients who are eligible for resection are exposed to high procedure-related morbidity and mortality, and despite apparent R0 resection, cancer recurrence is common. The benefit of R1 resection compared to the best palliative chemotherapy has been questioned. The concept of extended surgery to achieve better radicality is controversial and in many instances, associated with higher procedure-related risk and unclarified oncological benefit. For unresectable patients, liver transplantation, per the Mayo protocol, remains the only alternative for a few patients.

Optimal staging pre- and intraoperatively is problematic since only the local biliary ductal involvement and, to a certain extent, lymph node dissemination can be reasonably correctly assessed. The reliability and validity of the intraoperative frozen section have been questioned. Furthermore, microscopic tumor cell affection leading to recurrent disease has been found in 16% of presumed N0 lymph nodes when analyzed by immunohistochemistry, and patients with nodal micrometastasis showed the same dismal survival as those with positive nodes on regular pathology (pN1).

Taken together, there is a lack of good surgical options for patients with marginally or unresectable phCCA that do not satisfy current criteria for liver transplantation.

The practical problem in the current surgical techniques for hilar cholangiocarcinoma, particularly in locally advanced disease, is that the hepatoduodenal ligament, in most instances, represents an incompletely staged operative field, making the probability of obtaining true free margins uncertain.

An alternative procedure must, therefore, consider the anatomical and multidimensional pattern of dissemination and the limitations in the accurate staging of phCCA, and this suggests that a wider surgical margin is needed to obtain radical resection in locally advanced phCCA.

The aim of the current study is tho these the following hypothesis:

Locally advanced hilar cholangiocarcinoma without M1 lymph node metastatic disease can be radically resected by extending the surgical margin to include the complete hepatobiliary axis and the main anatomical trajectories of local and regional dissemination through an "en-bloc" surgical approach.

M1 metastatic disease is defined as positive nodes in the following locations at staging:

* Station 9: lymph nodes around the celiac axis.
* Station 14: lymph nodes along the superior mesenteric artery or vein.
* Station 15: lymph nodes along the middle colic vein.
* Station 16: para-aortic lymph nodes.

Patients will be treated by chemotherapy and radiation therapy with an observation period of at least 6 months showing response or stable disease before final inclusion.

The operative procedure consists of a superior right abdominal exenteration, including the liver, pancreas, spleen, and vena cava + liver transplantation. If islets are available from the same donor, this will be administered postoperatively according to the institutional protocol.

Main enpoint is overall survival at 1, 3 and 5 years

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Present and future of liver transplantation for cholangiocellular carcinoma: moving toward personalized multiparametric transplantability patterns.
   Cillo U, Furlanetto A, Lanari J, Nieddu E, et al · · 2026 · PMID 42183187 · DOI 10.3389/ti.2026.15786