Trial document




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  DRKS00018842

Trial Description

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Title

Pylorus resection versus pylorus preservation in pancreatoduodenectomy: A multicenter surgical registry-based randomized active-controlled trial (RRCT) from the German DGAV StuDoQ|Pancreas Registry

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Trial Acronym

PyloResPres-TRIAL

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URL of the Trial

[---]*

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Brief Summary in Lay Language

As part of a partial pancreatoduodenectomy (PD), two different strategies for the separation of the gastrointestinal passage are applied orally. This is on the one hand the resection (prPD) and on the other the receipt (ppPD) of the pylorus. Delayed gastric emptying (DGE) after PD is a serious complication that can occur following both strategies (ppPD or prPD). Existing metaanalyzes that examine the DGE after performing one of the two methods still produce conflicting results. Large, multicenter randomized controlled trials (RCTs) on this topic do not exist. The proposed study will now address this very shortcoming. In a prospective multi-centric and register-based RCT (RRCT), the effectiveness of ppPD should be compared with that of prPD in German nationwide reality. This novel study design allows a better transferability of the results.

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Brief Summary in Scientific Language

As part of a partial pancreatoduodenectomy (PD), two different strategies for the separation of the gastrointestinal passage are applied orally. This is on the one hand the resection (prPD) and on the other the receipt (ppPD) of the pylorus. Delayed gastric emptying (DGE) after PD is a serious complication that can occur following both strategies (ppPD or prPD). Existing metaanalyzes that examine the DGE after performing one of the two methods still produce conflicting results. Large, multicenter randomized controlled trials (RCTs) on this topic do not exist. The proposed study will now address this very shortcoming. In a prospective multi-centric and register-based RCT (RRCT), the effectiveness of ppPD should be compared with that of prPD in German nationwide reality. This novel study design allows a better transferability of the results.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00018842
  •   2019/10/24
  •   [---]*
  •   yes
  •   Approved
  •   19-221, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K31.9 -  Disease of stomach and duodenum, unspecified
  •   T81.9 -  Unspecified complication of procedure
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Interventions/Observational Groups

  •   pylorus preserving group (ppPP)
  •   pylorus resecting group (prPD)
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Characteristics

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

Primary efficacy endpoint is the frequency of postoperative DGE (delayed gastric emptying) according to the international ISGPS definition 30 days after index operation, compared between the two intervention groups

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Secondary Outcome

severe morbidity (Clavien Dindo classification<3b vs ≥3b), blood loss (ml), 30 day mortality (death from any cause), postoperative hospital stay, insufficiency of the gastro/pylorojejunostomy, operation time, initiation of adjuvant chemotherapy in cancer patients

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/11/26
  •   982
  •   Multicenter 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 in which a partial pancreatoduodenectomy (PD) needs to be performed
Any patient aged 18 years or older scheduled for PD for any indication with written informed consent is eligible

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Exclusion Criteria

-Patients who participate in another intervention trial interfering with the surgical intervention or the outcome of this Trial
-Patients with expected lack of compliance and/or irreconcilable language barriers will be excluded
-Classic Whipple operation

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Addresses

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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie LMU, Klinikum der Universität München Campus Großhadern
    • Mr.  Univ.-Prof. Dr.  Jens  Werner 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • German Society for General and Visceral Surgery (DGAV) Haus der Bundespressekonferenz
    • Mr.  Prof. Dr. med.  Heinz  Buhr 
    • Schiffbauerdamm 40
    • 10117  Berlin
    • Germany
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    •   +49 30 2345 8656-20
    •   [---]*
    •   hbuhr at dgav.de
    •   [---]*
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    • Klinik für Allgemein-, Viszeral- und Onkologische Chirugie, Klinikum Bremen-Mitte/Bremen-Ost
    • Mr.  Prof. Dr.  Hüseyin  Bektas 
    • Germany
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    • Klinik für Allgemein-, Thorax-und Viszeralchirugie, Städtisches Klinikum Dresden Friedrichstadt
    • Mr.  Prof. Dr.  Sören Torge   Mees 
    • Germany
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    • Klinik für Allgemein- und Viszeralchirugie, Helios Klinikum Erfurt
    • Mr.  Prof. Dr.  Albrecht  Stier 
    • Germany
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    • Chirurgische Klinik Universitätsklinikum Erlangen
    • Mr.  Prof. Dr.  Robert  Grützmann 
    • Germany
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    • Klinik für Allgemein-, und Viszeralchirurgie Alfred Krupp Krankenhaus Essen
    • Mr.  Prof. Dr.  Marco  Niedergethmann 
    • Germany
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    • Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.  Stefan  Fichtner-Feigl 
    • Germany
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    • Klinik für Allgemein-, und Viszeralchirurgie,chirurgische Onkologie, Asklepios Klinik Barmbeck, Hamburg
    • Mr.  Prof. Dr.  Karl-Jürgen  Oldhafer 
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Westpfalz-Klinikum GmbH Kaiserslautern
    • Mr.  PD Dr.  Christian  Mönch 
    • Germany
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    • Klinik für Chirurge, Universotätsklinikum Schleswig Holstein Campus Lübeck
    • Mr.  Prof. Dr.  Tobias  Keck 
    • Germany
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    • Klinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Marburg
    • Mr.  Prof. Dr.  Detlef K.  Bartsch 
    • Germany
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    • Klinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie Klinikum Memmingen
    • Mr.  Prof. Dr.  Carsten  Gutt 
    • Germany
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    • Klinik und Poliklinik für Chirurgie Klinikum Rechts der Isar der TU München
    • Mr.  Prof. Dr.  Helmut  Friess 
    • Germany
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    • Klinik für Allgemein- und Viszeralchirurgie Krankenhaus Barmherzige Brüder Regensburg
    • Mr.  Prof. Dr.  Pompiliu  Piso 
    • Germany
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    • Klinik für Allgemein- und Viszeralchirurgie St.Josephs Krankenhaus Wiesbaden
    • Mr.  Prof. Dr.  Stefan A.  Farkas 
    • Germany
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    • Universitätsklinik für Allgemein-, Viszeral- und Thoraxchirurgie der Paracelsus Medizinischen Privatuniversität am Klinikum Nürnberg
    • Mr.  Prof. Dr.  Hubert  Stein 
    • Prof.-Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
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    • Niels-Stensen-Kliniken Marienhospital Osnabrück Klinik für Allgemein- und Viszeralchirurgie
    • Mr.  Prof. Dr.  Christoph  Nies 
    • Bischofsstraße 1
    • 49074  Osnabrück
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum der Universität München Campus Großhadern
    • Mr.  Priv.-Doz. Dr. med  Bernhard  Renz 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum der Universität München Campus Großhadern
    • Mr.  Priv.-Doz. Dr. med  Bernhard  Renz 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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