Trial document




drksid header

  DRKS00004191

Trial Description

start of 1:1-Block title

Title

Pylorus Resection or Pylorus Preservation in partial Pancreatico-Duodenectomy: A randomized controlled trial (PROPP study).

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PROPP

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The study compares two different surgical techiques of partial pancreatico-duodenectomy ("Whipple" operation) as the standard treatmetn for pathologies of the pancreatic head. Aim is the comparison of pylorus preservation and pylorus resection in this surgical procedure. The effect of these techiques on oral food intake and delayed gastric emptying will be investigated.
Patients (18 years and older) undergoing an elective partial pancreaticoduodenctomy for any indication will be included after information and consent. Two randomized study groups will be included:

1.) operation with preservation of the pylorus
2.) operation with resection of the pylorus

Clinical course of oral intake and quality of life in 30-day postoperative period will be compared.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Partial pancreatico-duodenectomy (PD) is the standard treatment for tumors of the pancreatic head. Today, preservation of the pylorus has been widely accepted as the surgical standard in this procedure. A common postoperative complication is the occurrence of delayed gastric emptying (DGE) which is observed in up to 45% of the aptients and causes impairment of oral intake, patients’ quality of life, prolongation of hospital stay and delay of further treatment (e.g. adjuvant chemotherapy). In a small number of two retrospective and one randomized studies, a modification by resection of the pylorus under preservation of the stomach has shown to reduce DGE incidence. Aim of the present study is to create further evidence on the efficacy of pylorus resection on postoperative DGE in PD.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004191
  •   2012/06/29
  •   [---]*
  •   yes
  •   Approved
  •   S-121/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1138-7972 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C25.0 -  Malignant neoplasm: Head of pancreas
  •   D13.6 -  Benign neoplasm: Pancreas
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   pylorus-preserving partial pancreatico-duodenectomy
  •   partial pancreatico-duodenectomy with resection of the pylorus
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

delayed gastric emptying (DGE) after partial pancreatico-duodenectomy within 30 days, evaluation on d 7, 14 and 30 according to the ISGPS (International Study Group of Pancreatic Surgery) definition (see references)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

operation time, blood loss, morbidity according to the Clavien-Dindo classification, 30-day mortality, hospital stay, quality of life 30 days postoperative (EORTC QLQ PAN 26)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/03/01
  •   178
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

elective partial pancreatico-duodenectomy, 18 years or older, written informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

impaired possibility for consent (mental or language),
other studies interfering with the PROPP trial,
no written informed consent

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Allgemeine, Viszerale und Transplantationschirurgie Universität Heidelberg
    • Mr.  Prof. Dr. med.  Thilo  Hackert 
    • INF 110
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Thilo   Hackert 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Thilo  Hackert 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.