Trial document




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  DRKS00013552

Trial Description

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Title

Conventional partial pancreatoduodenectomy versus an uncinate first, extended partial pancreatoduodenectomy approach for the resection of pancreatic head ductal adenocarcinoma (PancER)

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Trial Acronym

PancER

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In patients with pancreatic ductal adenocarcinoma of the pancreatic head, surgical therapy involves removal of the pancreatic head and duodenum. Since the prognosis of the disease depends on surgical margin clearance, the PancER study investigates whether extended resection along the adjacent vessels increaseS the rate of microscopically-free tumor margins.

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Brief Summary in Scientific Language

The aim of the trial is to investigate whether an extended duodenopancreatectomy using the "uncinate first" method, a modified Kocher maneuver and a systematic mesopancreatic dissection in comparison with conventional pancreatoduodenectomy reduces the rate of pathologically complete resections (R0 and R0 (CRM +)) can increase significantly in patients with pancreatic carcinoma.

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Organizational Data

  •   DRKS00013552
  •   2018/01/02
  •   [---]*
  •   yes
  •   Approved
  •   S-421/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1205-4948 
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Health Condition or Problem studied

  •   C25.0 -  Malignant neoplasm: Head of pancreas
  •   C25.3 -  Malignant neoplasm: Pancreatic duct
  •   C25.8 -  Malignant neoplasm: Overlapping lesion of pancreas
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Interventions/Observational Groups

  •   Extended partial pancreatoduodenectomy with „Uncinate first“ method
  •   Conventional partial pancreatoduodenectomy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Rate of curative resections defined as microscopically complete (>0.1cm margin clearance; R0) and microscopic margin clearance <0.1cm (R0(CRM+)) resections according to a standardized protocol for pathologic evaluation

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Secondary Outcome

1. Rate of superficial and deep surgical site infections according to CDC criteria within 30 days after the index operation in both groups
2. Rate of the following postoperative complications:
- Postoperative pancreatic fistula (POPF) as defined by the ISGPS
- Postpancreatectomy hemorrhage as defined by the ISGPS
- Delayed gastric emptying as defined by the ISGPS
- Lymphatic fistula as defined by the ISGPS
- Diarrhea as defined and graded by the CTCAE version 4.03
- Other postoperative complications graded according to the Clavien-Dindo classification
3. Overall survival within 2 years
4. Local recurrence within 2 years
5. Quality of life according to EORTC QLQ-C30 and PAN26
6. Length of primary hospital stay in days
7. Serious adverse events in both groups

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/04/10
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients scheduled for elective partial pancreatoduodenectomy for suspected pancreatic ductal adenocarcinoma of the pancreatic head
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent
- Age ≥18 years

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Exclusion Criteria

- Status post neoadjuvant therapy for the suspected pancreatic ductal adenocarcinoma
- Participation in another interventional trial with interference of intervention and outcome of this Trial
- American Society of Anesthesiologists (ASA) grade > 3
- Pregnant or lactating women

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und TransplantationschirurgieUniversitätsklinikum Heidelberg
    • Mr.  PD Dr. med.  André  Mihaljevic 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und TransplantationschirurgieUniversitätsklinikum Heidelberg
    • Mr.  PD Dr. med.  André  Mihaljevic 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemein-, Viszeral- und TransplantationschirurgieUniversitätsklinikum Heidelberg
    • Mr.  PD Dr. med.  André  Mihaljevic 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.