ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer (ToPanc)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Procedure: Total pancreatectomy (TP); Procedure: Partial pancreaticoduodenectomy (PD)

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:

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.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna S Wenning, MD, PhD; Phone Number: +41 (0)31 632 71 41; Email: annasilvia.wenning@insel.ch
• Study Contact Backup: Name: Nadine Uebersax; Phone Number: +41 (0)31 684 33 69; Email: nadine.uebersax@unibe.ch

Study Locations

• Switzerland
  • Baden, Switzerland, 5404
    • Recruiting
    • Department of Surgery, Kantonsspital Baden
    • Contact: Prof. Dr. med. Antonio Nocito; Phone Number: +41 56 486 30 02; Email: antonio.nocito@ksb.ch
  • Basel, Switzerland, 4031
    • Not yet recruiting
    • Department of Visceral Surgery, University Hospital Basel
    • Contact: Prof. Dr. med. Beat Müller; Phone Number: +41 61 777 73 03; Email: beat.mueller@clarunis.ch
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Bern University Hospital
    • Contact: Anna S Wenning, MD, PhD
    • Principal Investigator: Anna S Wenning, MD, PhD
  • Geneva, Switzerland, 1205
    • Recruiting
    • Department of Visceral Surgery, University Hospital Geneva
    • Contact: Prof. Dr. med. Christian Toso; Phone Number: +41 22 372 77 02; Email: christian.toso@hug.ch
  • Sankt Gallen, Switzerland, 9000
    • Recruiting
    • Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen
    • Contact: PD Dr. med. Ignazio Tarantino; Phone Number: +41 71 494 13 12; Email: ignazio.tarantino@h-och.ch
  • Zurich, Switzerland, 8063
    • Not yet recruiting
    • Department of Surgery, Stadtspital Triemli Zürich
    • Contact: Dr. med. Stefan Gutknecht; Phone Number: +41 44 416 43 61; Email: stefan.gutknecht@stadtspital.ch
  • Zurich, Switzerland, 8091
    • Recruiting
    • Department of Surgery and Transplantation, University Hospital Zürich
    • Contact: Prof. Dr. med. José Oberholzer; Phone Number: +41 44 255 33 00; Email: jose.oberholzer@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Total pancreatectomy (TP)	Procedure: Total pancreatectomy (TP); The investigators perform TP in patients who undergo surgical resection of a malignant tumor in the pancreatic head.
Active Comparator: Pancreaticoduodenectomy (PD)	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Number of participants who survived for 2 years after surgery.	At 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	Within 30 day of surgery
Mortality	Number of participants who died.	Within 30 days of surgery
Length of hospital stay in days		Within 30 days of surgery
Re-admission	Number of participants who were re-admitted to the hospital.	Within 30 days of surgery
Re-operation	Number of participants who required a re-operation.	Within 30 days of surgery
Adjuvant Chemotherapy (ACT) initiation	Number of days from surgery to ACT initiation.	At 1 year
Adjuvant Chemotherapy (ACT) completion	Number of days from surgery to ACT completion.	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).	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.	At 0.5 year, at 1 year, at 2 years
Body Mass Index (BMI)		At 0.5 year, at 1 year, at 2 years

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Anna S Wenning, MD, PhD, Department of Visceral Surgery and Medicine Inselspital, Bern University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 2024-02010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No