Pancreatic CancerToPancNCT06801899
ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer
A study testing Total pancreatectomy (TP) and Partial pancreaticoduodenectomy (PD) in people with Pancreatic Cancer, run by Insel Gruppe AG, University Hospital Bern at 10 sites in 2 countries.
Trial summary
The goal of this clinical trial is to learn if total removal of the pancreas is a preferable alternative to partial removal in patients with cancer of the pancreatic head who are at high risk of pancreatic leakage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Total pancreatectomy (TP) and Partial pancreaticoduodenectomy (PD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 1 Jun 2026to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years) scheduled to undergo PD for highly suspected or histologically proven, resectable pancreatic ductal adenocarcinoma (PDAC), distal cholangiocarcinoma (DCC), and/or ampullary cancer (pancreaticobiliary type)
- Suspected pancreas anastomosis at high-risk for development of a postoperative pancreatic fistula (POPF) (grade "D" according to Schuh et al. (29): Estimation by CT scan, MRI, and/or Endoscopic Ultrasound
- Written informed consent
Who cannot join
- Duodenal carcinoma, ampullary cancer (intestinal type), neuroendocrine tumors, benign tumors, chronic pancreatitis
- Medical conditions that do not allow appreciation of the nature, scope, and possible consequences of the trial as judged by the investigator
- Pregnancy. A beta-Human Chorionic Gonadotropin (bHCG) pregnancy test must to be performed for women of child-bearing potential (defined as premenopausal women who have not undergone surgical sterilization)
- Inability to follow the study procedures, e.g., due to psychological disorders, dementia, etc.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
Switzerland8 sites, 8 recruiting
- Recruiting
Department of General and Visceral Surgery, Kantonsspital Aarau
Aarau, 5001
PD Dr. med. Philipp Kron, +41 62 838 55 80, philipp.kron@ksa.ch
- Recruiting
Department of Surgery, Kantonsspital Baden
Baden, 5404
Prof. Dr. med. Antonio Nocito, +41 56 486 30 02, antonio.nocito@ksb.ch
- Recruiting
Department of Visceral Surgery, University Hospital Basel
Basel, 4031
Prof. Dr. med Adrian Billeter, +41 61 777 73 21, adrian.billeter@clarunis.ch
- Recruiting
Inselspital, Bern University Hospital
Bern, 3010
Anna S Wenning, MD, PhD
Anna S Wenning, MD, PhD
- Recruiting
Department of Visceral Surgery, University Hospital Geneva
Geneva, 1205
Prof. Dr. med. Christian Toso, +41 22 372 77 02, christian.toso@hug.ch
- Recruiting
Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen
Sankt Gallen, 9000
PD Dr. med. Ignazio Tarantino, +41 71 494 13 12, ignazio.tarantino@h-och.ch
- Recruiting
Department of Surgery, Stadtspital Triemli Zürich
Zurich, 8063
Dr. med. Stefan Gutknecht, +41 44 416 43 61, stefan.gutknecht@stadtspital.ch
- Recruiting
Department of Surgery and Transplantation, University Hospital Zürich
Zurich, 8091
Prof. Dr. med. José Oberholzer, +41 44 255 33 00, jose.oberholzer@usz.ch
Germany2 sites, 2 recruiting
- Recruiting
Department of General, Visceral and Transplantation Surgery, University Hospital Münster
Münster, 48149
Prof. Dr. med. Andreas Pascher, +49 251 83 56304, sekretariatavtc@ukmuenster.de
- Recruiting
Department of General and Visceral Surgery, University Hospital Ulm
Ulm, 89081
Prof. Dr. med. Emrullah Birgin, +49 731 500 53 501, emrullah.birgin@uniklinik-ulm.de
About this study
Official title: ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer: a Multi-centric Randomized Controlled Trial
The goal of this clinical trial is to learn if total removal of the pancreas is a preferable alternative to partial removal in patients with cancer of the pancreatic head who are at high risk of pancreatic leakage. The main question it aims to answer is:
Does total pancreas removal improve survival without reducing quality of life compared to partial removal?
The only study specific procedures are the collection of 2 blood samples (7.5ml for each time point, preoperatively and during the hospitalisation) and the completion of the questionnaires.
Read the detailed description
The pancreas is located in the upper abdomen and has 2 main functions: Production of digestive juices and of insulin, the latter being most important for blood sugar regulation and energy conservation. Certain types of cancer in the pancreatic head are very aggressive, but with complete surgical removal of the tumor and additional chemotherapy cure is possible. For tumor resection, the head of the pancreas as well as duodenum and part of the bile duct are removed. 3 new connections are built: the remaining pancreas, bile duct and stomach are connected to a loop of small intestine.
This operation takes around 6 hours and leads to complications in 20-30% of cases. A serious complication and unfortunately the most frequent is the leaking of the pancreas remnant, with outflow of the aggressive digestive juice into the surrounding tissue. Consequences may be severe bleeding and/or infections. Many studies show that affected patients have an increased risk of tumor recurrence and a reduced survival.
To avoid pancreatic leak, the entire pancreas can be removed. So far, removal of the whole pancreas has only been chosen in cases of very advanced cancer. After both, partial or total pancreas removal, patients need to substitute digestive enzymes. This can be done by capsules, which need to be taken with every meal. But while some patients after partial removal maintain sufficient function to produce insulin, all patients after total removal are diabetic and need insulin injections. In the past, blood sugar control in the absence of insulin production was difficult and accompanied by low quality of life (QoL). This has changed tremendously by the introduction of continuous glucose monitoring (sensors, which are attached to the arm) and automated insulin delivery systems (also known as "artificial pancreas"). This development renders total pancreas removal a reasonable alternative, with the advantage, that only 2 new connections are made: One between the bile duct and small intestine and one between the stomach and the small intestine.
Study question: Is removal of the whole pancreas in patients at high risk of a pancreatic leakage a preferable alternative to partial removal?
For this study, patients with cancer of the pancreatic head who are planned for surgery can be included. These patients will be randomly assigned to two groups:
- Standard group: partial removal of the pancreas
- Study group: total removal of the pancreas
Both techniques are safe and are established techniques to treat cancer in the pancreatic head. After the operation, many clinical data will be recorded. The two most important factors will be survival and quality of life, which will be assessed by questionnaires on a regular base. Additionally, postoperative complications, chemotherapy rates, tumor recurrence and many more data will be monitored.
- Conditions
- Pancreatic Cancer
- Being tested
- Total pancreatectomy (TP), Partial pancreaticoduodenectomy (PD)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total pancreatectomy (TP)Procedure or surgery
The investigators perform TP in patients who undergo surgical resection of a malignant tumor in the pancreatic head.
Partial pancreaticoduodenectomy (PD)Procedure or surgery
The investigators perform partial PD with anastomosis of the pancreas in patients who undergo surgical resection of a malignant tumor in the pancreatic head. This is the current standard procedure.
| Study group | Role | What they receive |
|---|---|---|
| Total pancreatectomy (TP) | Experimental | Not described Receives: Procedure: Total pancreatectomy (TP) |
| Pancreaticoduodenectomy (PD) | Active comparator | Not described Receives: Procedure: Partial pancreaticoduodenectomy (PD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Number of participants who survived for 2 years after surgery.
Measured: At 2 years
Secondary outcomes (12)
Quality of Life (QoL) Pancreatic Cancer
Recorded as participant-reported outcome. Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for pancreatic cancer (EORCT QLQPAN26). Scale from 0 to 104, with higher scores indicating a greater level of symptoms or problems.
Measured: At 0.5 year, at 1 year, at 2 years
Quality of Life (QoL) Diabetes
Recorded as participant-reported outcome. Measured by Diabetes Distress Scale (DDS) 17 Questionnaire (only for patients with insulin-dependent diabetes). Scale from 17 to 102, with higher scores indicating a greater level of distress.
Measured: At 0.5 year, at 1 year, at 2 years
Postoperative complications (discriminating minor and major complications)
Number of participants with postoperative complications. Classified according to the Clavien-Dindo-classification (major complication defined as Clavien-Dindo Grade ≥ III).
Measured: Within 90 day of surgery
Mortality
Number of participants who died.
Measured: Within 90 days of surgery
Length of hospital stay in days
Measured: Within 90 days of surgery
Re-admission
Number of participants who were re-admitted to the hospital.
Measured: Within 90 days of surgery
Re-operation
Number of participants who required a re-operation.
Measured: Within 90 days of surgery
Adjuvant Chemotherapy (ACT) initiation
Number of days from surgery to ACT initiation.
Measured: At 1 year
Adjuvant Chemotherapy (ACT) completion
Number of days from surgery to ACT completion.
Measured: At 1 year
Disease-Free Survival (DFS)
Number of participants who remained free of disease. Defined as no new metastasis or local recurrence on CT or MRI imaging, and, if applicable, laboratory tests (new Ca19-9 increase).
Measured: At follow-up, up to 4.5 years
Functional status
Recorded as participant-reported outcome. Measured by Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. Scale from 1 to 5, with higher scores indicating a greater level of disability.
Measured: At 0.5 year, at 1 year, at 2 years
Body Mass Index (BMI)
Measured: At 0.5 year, at 1 year, at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Jun 2026
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna S Wenning, MD, PhD, Principal investigator, Department of Visceral Surgery and Medicine Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801899
- Sponsor's protocol ID
- 2024-02010
- Acronym
- ToPanc
- Status last verified
- Aug 2026
- First submitted
- 24 Jan 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer: a Multi-centric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06801899
- Acronym / sponsor ID
- ToPanc / 2024-02010
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 30 Jan 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.
The goal of this clinical trial is to learn if total removal of the pancreas is a preferable alternative to partial removal in patients with cancer of the pancreatic head who are at high risk of pancreatic leakage. The main question it aims to answer is:
Does total pancreas removal improve survival without reducing quality of life compared to partial removal?
The only study specific procedures are the collection of 2 blood samples (7.5ml for each time point, preoperatively and during the hospitalisation) and the completion of the questionnaires.
Detailed description
The pancreas is located in the upper abdomen and has 2 main functions: Production of digestive juices and of insulin, the latter being most important for blood sugar regulation and energy conservation. Certain types of cancer in the pancreatic head are very aggressive, but with complete surgical removal of the tumor and additional chemotherapy cure is possible. For tumor resection, the head of the pancreas as well as duodenum and part of the bile duct are removed. 3 new connections are built: the remaining pancreas, bile duct and stomach are connected to a loop of small intestine.
This operation takes around 6 hours and leads to complications in 20-30% of cases. A serious complication and unfortunately the most frequent is the leaking of the pancreas remnant, with outflow of the aggressive digestive juice into the surrounding tissue. Consequences may be severe bleeding and/or infections. Many studies show that affected patients have an increased risk of tumor recurrence and a reduced survival.
To avoid pancreatic leak, the entire pancreas can be removed. So far, removal of the whole pancreas has only been chosen in cases of very advanced cancer. After both, partial or total pancreas removal, patients need to substitute digestive enzymes. This can be done by capsules, which need to be taken with every meal. But while some patients after partial removal maintain sufficient function to produce insulin, all patients after total removal are diabetic and need insulin injections. In the past, blood sugar control in the absence of insulin production was difficult and accompanied by low quality of life (QoL). This has changed tremendously by the introduction of continuous glucose monitoring (sensors, which are attached to the arm) and automated insulin delivery systems (also known as "artificial pancreas"). This development renders total pancreas removal a reasonable alternative, with the advantage, that only 2 new connections are made: One between the bile duct and small intestine and one between the stomach and the small intestine.
Study question: Is removal of the whole pancreas in patients at high risk of a pancreatic leakage a preferable alternative to partial removal?
For this study, patients with cancer of the pancreatic head who are planned for surgery can be included. These patients will be randomly assigned to two groups:
- Standard group: partial removal of the pancreas
- Study group: total removal of the pancreas
Both techniques are safe and are established techniques to treat cancer in the pancreatic head. After the operation, many clinical data will be recorded. The two most important factors will be survival and quality of life, which will be assessed by questionnaires on a regular base. Additionally, postoperative complications, chemotherapy rates, tumor recurrence and many more data will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total pancreatectomy (TP) | Experimental | Procedure: Total pancreatectomy (TP) |
| Pancreaticoduodenectomy (PD) | Active comparator | Procedure: Partial pancreaticoduodenectomy (PD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age ≥ 18 years) scheduled to undergo PD for highly suspected or histologically proven, resectable pancreatic ductal adenocarcinoma (PDAC), distal cholangiocarcinoma (DCC), and/or ampullary cancer (pancreaticobiliary type)
- Suspected pancreas anastomosis at high-risk for development of a postoperative pancreatic fistula (POPF) (grade "D" according to Schuh et al. (29): Estimation by CT scan, MRI, and/or Endoscopic Ultrasound
- Written informed consent
Key exclusion criteria (4 listed)
- Duodenal carcinoma, ampullary cancer (intestinal type), neuroendocrine tumors, benign tumors, chronic pancreatitis
- Medical conditions that do not allow appreciation of the nature, scope, and possible consequences of the trial as judged by the investigator
- Pregnancy. A beta-Human Chorionic Gonadotropin (bHCG) pregnancy test must to be performed for women of child-bearing potential (defined as premenopausal women who have not undergone surgical sterilization)
- Inability to follow the study procedures, e.g., due to psychological disorders, dementia, etc.
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 |
|---|---|---|
| Total pancreatectomy (TP)The investigators perform TP in patients who undergo surgical resection of a malignant tumor in the pancreatic head. | Procedure or surgery | Total pancreatectomy (TP) |
| Partial pancreaticoduodenectomy (PD)The investigators perform partial PD with anastomosis of the pancreas in patients who undergo surgical resection of a malignant tumor in the pancreatic head. This is the current standard procedure. | Procedure or surgery | Pancreaticoduodenectomy (PD) |
Primary outcome
Overall survival (OS)
Time frame: At 2 years
Number of participants who survived for 2 years after surgery.
12 secondary outcomes
Quality of Life (QoL) Pancreatic Cancer
Time frame: At 0.5 year, at 1 year, at 2 years
Quality of Life (QoL) Diabetes
Time frame: At 0.5 year, at 1 year, at 2 years
Postoperative complications (discriminating minor and major complications)
Time frame: Within 90 day of surgery
Mortality
Time frame: Within 90 days of surgery
Length of hospital stay in days
Time frame: Within 90 days of surgery
Re-admission
Time frame: Within 90 days of surgery
Re-operation
Time frame: Within 90 days of surgery
Adjuvant Chemotherapy (ACT) initiation
Time frame: At 1 year
Adjuvant Chemotherapy (ACT) completion
Time frame: At 1 year
Disease-Free Survival (DFS)
Time frame: At follow-up, up to 4.5 years
Functional status
Time frame: At 0.5 year, at 1 year, at 2 years
Body Mass Index (BMI)
Time frame: At 0.5 year, at 1 year, at 2 years
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 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Anna S Wenning, MD, PhD principal investigator
Department of Visceral Surgery and Medicine Inselspital, Bern University Hospital
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total pancreatectomy (TP) and Partial pancreaticoduodenectomy (PD) in people with Pancreatic Cancer, run by Insel Gruppe AG, University Hospital Bern at 10 sites in 2 countries.
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 3 inclusion and 4 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland, Germany. 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 Anna S Wenning, MD, PhD (+41 (0)31 632 71 41, annasilvia.wenning@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: At 2 years). 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 12 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.