Cholangiocarcinoma Non-resectableSURE-LTNCT06850753
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
A study testing Liver transplantation after en bloc resection of the liver and pancreas in people with Cholangiocarcinoma Non-resectable and Cholangiocarcinoma Recurrent, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholangiocarcinoma Non-resectable, Cholangiocarcinoma Recurrent, Liver Transplantation
- What is being tested?
- Liver transplantation after en bloc resection of the liver and pancreas
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified or strong suspicion of cholangiocarcinoma based on radiology and endoscopy and elevated Ca 19-9 > 100U/L
- Perihilar cholangiocarcinoma that is deemed unresectable based on tumor location or severity of the underlying liver disease. Perihilar recurrence in PSC patients more than 24 months following the previous resection (N0, R0, no macrovascular involvement) is accepted.
- Patients should not be eligible for liver transplantation according to the Mayo protocol criteria.
- Tumor involvement of the hepatic artery distal to the gastroduodenal artery or the portal vein without tumor thrombus is accepted.
- No evidence of distant metastasis or metastatic lymph node (M1) involvement (para-aortic, coeliac or para-colic)
- Good performance status Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
- At least 6 months of observation time during which the patient should be treated by chemotherapy and radiation (hyperfractioned 30-50 Gy) with response or stable disease before listing for LT. Patients with PSC and significant liver dysfunction that restricts the tolerability of chemoradiotherapy may be considered on an individual basis
Who cannot join
- Radiological signs of tumor invasion along intended resection borders
- Direct tumor invasion of the pancreatic head
- Signs of spread to the para-aortic, superior mesenteric, or coeliac lymph nodes
- Perforation of the visceral peritoneum
- Weight loss >10% in the last six months
- Patient BMI > 30 kg/m2
Show all 13Show fewer
- Other malignancies, except curatively treated basal cell carcinoma or other tumors with disease-free interval > five years without relapse. The final decision on acceptable previous cancer diagnoses is at the principal investigator's discretion.
- Known history of human immunodeficiency virus (HIV) infection
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Known hypersensitivity to rapamycin
- Prior metastatic disease
- Women who are pregnant or breastfeeding
- Any reason why, in the opinion of the investigator, the patient should not participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0424
Pål-Dag Line, MD PhD, 23070509 ext. +47, paaldl@uio.no
Sheraz Yaqub, MD PhD, 90953996 ext. +47, sheraz.yaqub@medisin.uio.no
About this study
Official title: Superior Right Abdominal Excentration and Liver Transplantation (SURE-LT) for Perihilar Cholangiocarcinoma
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).
Read more
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
- Being tested
- Liver transplantation after en bloc resection of the liver and pancreas
- Keywords
- hilar cholangiocarcinoma, Liver transplantation
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantation after en bloc resection of the liver and pancreasProcedure or surgery
Exenteration of the upper right part of the abdomen, including the liver and pancreas en bloc in locally advanced hilar cholangiocarcinoma, followed by liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation for locally advaced hilar cholangiocarcinoma | Experimental | Patients with hilar cholangiocarcinoma outside current transplant criteria will be treated with neoadjuvant chemotherapy + radiation and, after an observation period of a minimum of 6 months, undergo an exenteration of the liver and pancreas "en-bloc" + liver transplantation. Receives: Procedure: Liver transplantation after en bloc resection of the liver and pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Proportion of patients alive
Measured: 1, 3 and 5 years postoperatively
Secondary outcomes (4)
Disease-free survival
Proportion of patients without evidence of disease
Measured: 1,3 and 5 years postoperatively
Survival after recurrence
Survival time after diagnosis of cancer recurrence
Measured: months
Quality of life score
Quality of life will be measured using the European Organisation For Research And Treatment Of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30).
The 30-item list captures key symptoms and signs related to bodily and mental function, and each item is scored on a scale of 1-4. The minimum score is 30, and the maximum is 120. A high score signifies a reduced quality of life.
Measured: 6 and 12 months
Surgical complications
Surgical complications according to the Clavien Dindo classification and the Comprehensive Complication Index.
Measured: 90 days and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiocarcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Controlled prospective open-label trial to study liver transplantation in locally advanced hilar cholangiocarcinoma
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pål-Dag Line, Oslo University Hospital
- Investigators
- Pål-Dag Line, MD PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850753
- Sponsor's protocol ID
- REK743190
- Acronym
- SURE-LT
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is, for the time being, a single-site study. If the study is to include one or more sites, the IPD information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Right Abdominal Excentration and Liver Transplantation (SURE-LT) for Perihilar Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT06850753
- Acronym / sponsor ID
- SURE-LT / REK743190
- Keywords
- hilar cholangiocarcinoma, Liver transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Controlled prospective open-label trial to study liver transplantation in locally advanced hilar cholangiocarcinoma
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation for locally advaced hilar cholangiocarcinoma | Experimental | Procedure: Liver transplantation after en bloc resection of the liver and pancreasPatients with hilar cholangiocarcinoma outside current transplant criteria will be treated with neoadjuvant chemotherapy + radiation and, after an observation period of a minimum of 6 months, undergo an exenteration of the liver and pancreas "en-bloc" + liver transplantation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically verified or strong suspicion of cholangiocarcinoma based on radiology and endoscopy and elevated Ca 19-9 > 100U/L
- Perihilar cholangiocarcinoma that is deemed unresectable based on tumor location or severity of the underlying liver disease. Perihilar recurrence in PSC patients more than 24 months following the previous resection (N0, R0, no macrovascular involvement) is accepted.
- Patients should not be eligible for liver transplantation according to the Mayo protocol criteria.
- Tumor involvement of the hepatic artery distal to the gastroduodenal artery or the portal vein without tumor thrombus is accepted.
- No evidence of distant metastasis or metastatic lymph node (M1) involvement (para-aortic, coeliac or para-colic)
Key exclusion criteria (13 listed)
- Radiological signs of tumor invasion along intended resection borders
- Direct tumor invasion of the pancreatic head
- Signs of spread to the para-aortic, superior mesenteric, or coeliac lymph nodes
- Perforation of the visceral peritoneum
- Weight loss >10% in the last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantation after en bloc resection of the liver and pancreasExenteration of the upper right part of the abdomen, including the liver and pancreas en bloc in locally advanced hilar cholangiocarcinoma, followed by liver transplantation | Procedure or surgery | Liver transplantation for locally advaced hilar cholangiocarcinoma |
Primary outcome
Overall survival
Time frame: 1, 3 and 5 years postoperatively
Proportion of patients alive
4 secondary outcomes
Disease-free survival
Time frame: 1,3 and 5 years postoperatively
Survival after recurrence
Time frame: months
Quality of life score
Time frame: 6 and 12 months
Surgical complications
Time frame: 90 days and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No. This is, for the time being, a single-site study. If the study is to include one or more sites, the IPD information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pål-Dag Line, MD PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver transplantation after en bloc resection of the liver and pancreas in people with Cholangiocarcinoma Non-resectable and Cholangiocarcinoma Recurrent, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pål-Dag Line, MD PhD (23070509 ext. +47, paaldl@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1, 3 and 5 years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.