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

Organizational Data

DRKS-ID:
DRKS00018842
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2019-10-24
Last update in DRKS:
2021-11-19
Registration type:
Prospective

Acronym/abbreviation of the study

PyloResPres-TRIAL

URL of the study

No Entry

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.

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.

Health condition or problem studied

ICD10:
K31.9 - Disease of stomach and duodenum, unspecified
ICD10:
T81.9 - Unspecified complication of procedure
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
pylorus preserving group (ppPP)
Arm 2:
pylorus resecting group (prPD)

Endpoints

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
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

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center LMU München Klinikum Großhadern München
  • Medical center Klinik für Allgemein-, Thorax-und Viszeralchirugie, Städtisches Klinikum Dresden Friedrichstadt Dresden
  • Medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Westpfalz-KlinikumGmbH Kaiserslautern Kaiserslautern
  • University medical center Klinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Marburg Marburg
  • Medical center Klinik für Allgemein- und Viszeralchirurgie Krankenhaus Barmherzige Brüder Regensburg Regensburg
  • Medical center Klinik für Allgemein-, Viszeral- und Onkologische Chirugie, Klinikum Bremen-Mitte/Bremen-Ost Bremen
  • Medical center Klinik für Allgemein-, und Viszeralchirurgie Alfred Krupp Krankenhaus Essen Essen
  • University medical center Klinik für Chirurge, UniversotätsklinikumSchleswig Holstein Campus Lübeck Lübeck
  • Medical center Klinik für Allgemein-, und Viszeralchirurgie,chirurgische Onkologie, Asklepios KlinikBarmbeck ,Hamburg Hamburg
  • Medical center Klinik für Allgemein-, und Viszeralchirurgie,chirurgische Onkologie, Asklepios KlinikBarmbeck ,Hamburg Hamburg
  • Medical center Klinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie Klinikum Memmingen Memmingen
  • University medical center Chirurgische Klinik Universitätsklinikum Erlangen Erlangen
  • University medical center Klinik und Poliklinik für Chirurgie KlinikumRechts der Isar der TU München München
  • University medical center Universitätsklinik für Allgemein-, Viszeral- und Thoraxchirurgie der Paracelsus Medizinischen Privatuniversität Nürnberg
  • Medical center Niels-Stensen-Kliniken Marienhospital Osnabrück Osnabrück
  • University medical center Klinik und Poliklinik für Allgemein-, Viszeral-, Tumor- und Transplantationschirurgie Uniklinik Köln Köln
  • Medical center Klinik für Allgemein-, Thorax- und Gefäßchirurgie Klinikum Südstadt Rostock Rostock
  • University medical center Klinik & Poliklinik für Allgemein-,Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie Zentrum Operative Medizin Universitätsklinikum Würzburg Würzburg
  • Medical center Klinik für Allgemein- und Viszeralchirurgie Ammerland-Klinik GmbH Westerstede
  • Medical center Klinik für Allgemein- und Viszeralchirurgie, endokrine Chirurgie und Coloproktologie München Klinik Neuperlach München
  • Medical center Department oberer Gastrointestinaltrakt Klinik für Allgemein-, Gefäß- und Thoraxchirurgie RoMed Klinikum Rosenheim Rosenheim
  • University medical center Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Bonn Bonn
  • Medical center Klinik für Allgemein- und Viszeralchirurgie St. Josefs-Hospital Katholisches Klinikum Bochum Bochum
  • Medical center Klinik für Allgemein- und Viszeralchirurgie Helios Klinik Schwerin GmbH Schwerin
  • Medical center Klinik für Allgemein-, Viszeral-, Endokrine und Onkologische Chirurgie Klinikum Fulda Fulda
  • Medical center Klinik für Allgemein-, Viszeral und Onkologische Chirurgie Evangelisches Krankenhaus Düsseldorf Düsseldorf
  • University medical center Allgemein,- Viszeral- und Transplantationschirurgie Universitätsklinikum Frankfurt Frankfurt a.M.
  • Medical center Klinik für Allgemein-, Viszeral- und Minimalinvasive Chirurgie Helios Klinikum Emil von Behring Berlin
  • Medical center Klinik für Chirurgie - Chirurgie II - Allgemein- und Visceralchirurgie St. Vinzenz-Hospital Köln
  • University medical center RWTH Aachen, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Aachen
  • University medical center Klinik für Allgemein-, Viszeral- und Kinderchirurgie Düsseldorf

Recruitment period and number of participants

Planned study start date:
2019-11-01
Actual study start date:
2019-11-26
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
982
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
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

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

Addresses

Primary Sponsor

LMU Klinikum München Anstalt des öffentlichen Rechts
Marchioninistr. 15
81377 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum der Universität München Campus Großhadern
Prof. Dr. med. Jens Werner
Marchioninistr. 15
81377 München
Germany
Telephone:
089/440072791
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum der Universität München Campus Großhadern
Priv.-Doz. Dr. med Bernhard Renz
Marchioninistr. 15
81377 München
Germany
Telephone:
089/4400711205
Fax:
089/440067574
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum der Universität München Campus Großhadern
Prof. Dr. med. Jens Werner
Marchioninistr. 15
81377 München
Germany
Telephone:
089/440072791
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Deutsche Forschungsgemeinschaft
Kennedyallee 40
53175 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dfg.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Med. Fakultät der LMU
Pettenkoferstraße 8
80336 München
Germany
Telephone:
+49-89-440055191
Fax:
+49-89-440055192
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2019-03-20
Ethics committee number:
19-221
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-07-29

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
After publication the data set will be available upon request for further research also to non-participating parties.

Study protocol and other study documents

Study protocols:
Study Protocol
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry