Trial document




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  DRKS00013503

Trial Description

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Title

Endoluminal Pyloromyotomy for the Reduction of Delayed Gastric Emptying after Pylorus Preserving Pancreaticoduodenectomy

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Trial Acronym

PORRIDGE trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Malignant and benign tumors of the pancreas as well as tumors of the papilla of Vater and the extrahepatic bile ducts often require a surgical (partial) resection of the pancreas and duodenum. A common complication after this surgical procedure is a delayed gastric emptying which has an adverse influence on postoperative food intake and quality of life.
This clinical study compares two established surgical steps during pylorus-preserving pancreatic resection. The aim of this study is to investigate if an incision of the pyloric muscle during the operation reduces the occurence of delayed gastric emptying compared to a stretching of the pyloric muscle during the operation.

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Brief Summary in Scientific Language

Prospective randomized controlled trial to compare intraoperative endoluminal pyloromyotomy with atraumatic stretching of the pyloric muscle during pylorus preserving pancreaticoduodenectomy with regard to postoperative delayed gastric emptying and quality of life.

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Organizational Data

  •   DRKS00013503
  •   2017/12/27
  •   [---]*
  •   yes
  •   Approved
  •   17-605, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   U1111-1205-7426 
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Health Condition or Problem studied

  •   C25 -  Malignant neoplasm of pancreas
  •   D37.70 -  [generalization D37.7: Neoplasm of uncertain or unknown behaviour: Other digestive organs]
  •   D13.6 -  Benign neoplasm: Pancreas
  •   C24.1 -  Malignant neoplasm: Ampulla of Vater
  •   D37.6 -  Neoplasm of uncertain or unknown behaviour: Liver, gallbladder and bile ducts
  •   D13.5 -  Benign neoplasm: Extrahepatic bile ducts
  •   C24.0 -  Malignant neoplasm: Extrahepatic bile duct
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Interventions/Observational Groups

  •   Intraoperative endoluminal pyloromyotomy prior to creation of the duodenojejunostomy
  •   Atraumatic stretching of pyloric muscle prior to creation of the duodenojejunostomy
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Characteristics

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

Presence of delayed gastric emptying (ISGPS definition) within 30 days after surgery

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Secondary Outcome

- Qualitiy of Life (assessed with EORTC QLQ-C30 and QLQ-PAN26 questionnaire) assessed preoperatively and on postoperative day 7, 14, 30 and 90
- severity / grade of delayed gastric emptying (ISGPS definition) within 30 days after surgery
- morbidity according to Clavien-Dindo-Classification within 30 days after surgery
- operation time
- length of hospital stay
- estimated blood loss

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/02/16
  •   112
  •   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 undergoing pylorus preserving pancreaticoduodenectomy

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Exclusion Criteria

Patients who are unable to consent and patients participating in other clinical trials that have a potential impact on the primary endpoint of this clinical trial will be excluded.

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Addresses

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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum Augsburg
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum Augsburg
    • Mr.  Prof. Dr. med.  Matthias  Anthuber 
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum Augsburg
    • Mr.  Prof. Dr. med.  Matthias  Anthuber 
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum Augsburg
    • Stenglinstrasse 2
    • 86156  Augsburg
    • 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.