ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer
NCT ID: NCT06801899
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2025-05-12
2029-07-31
Brief Summary
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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.
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Detailed Description
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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:
1. Standard group: partial removal of the pancreas
2. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Total pancreatectomy (TP)
Total pancreatectomy (TP)
The investigators perform TP in patients who undergo surgical resection of a malignant tumor in the pancreatic head.
Pancreaticoduodenectomy (PD)
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.
Interventions
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Total pancreatectomy (TP)
The investigators perform TP in patients who undergo surgical resection of a malignant tumor in the pancreatic head.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Anna S Wenning, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Visceral Surgery and Medicine Inselspital, Bern University Hospital
Locations
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Department of Surgery, Kantonsspital Baden
Baden, , Switzerland
Department of Visceral Surgery, University Hospital Basel
Basel, , Switzerland
Inselspital, Bern University Hospital
Bern, , Switzerland
Department of Visceral Surgery, University Hospital Geneva
Geneva, , Switzerland
Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Department of Surgery, Stadtspital Triemli Zürich
Zurich, , Switzerland
Department of Surgery and Transplantation, University Hospital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Anna S Wenning, MD, PhD
Role: primary
Other Identifiers
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2024-02010
Identifier Type: -
Identifier Source: org_study_id
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