Trial document

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DRKS-ID: DRKS00007784

Trial Description

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Title

Intravenous vs. epidural analgesia to reduce the incidence of gastrointestinal complications after elective pancreatoduodenectomy

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Trial Acronym

PAKMAN

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URL of the Trial

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Brief Summary in Lay Language

The effective treatment of pain after surgery has a positive effect on the recovery of patients. For major surgical procedures of the pancreas, pain management is already initiated during surgery and continued after surgery for several days as needed to alleviate pain sufficiently.
Currently, there are two different standard applications: one is the intravenous (administered through a vein) patient-controlled pain treatment, abbreviated IV-PCA, the other is the epidural (administered via a catheter near the spinal cord) pain treatment, abbreviated EDA.
The aim of the PAKMAN trial is to compare both procedures with respect to the occurrence of complications of the gastrointestinal tract (e.g. pancreatic fistula).

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Brief Summary in Scientific Language

The most common strategies for pain management in pancreatic surgery are either combined intraoperative general and epidural anesthesia and postoperative epidural analgesia (EDA) or intraoperative general anesthesia and postoperative patient-controlled intravenous analgesia (IV-PCA). Unfortunately, patients undergoing pancreatoduodenectomy often suffer from gastrointestinal complications, e. g. pancreatic fistula, delayed gastric emptying, biliary leakage, gastrointestinal bleeding, postoperativ ileus. Based on a previous trial, the aim of the PAKMAN trial is to compare These two procedures regarding the frequency of complications in a multicenter RCT setting. A total of 370 patients need to be randomized.

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Organizational Data

DRKS-ID: DRKS00007784
Date of Registration in DRKS: 2015/03/23
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: S-073/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg

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Secondary IDs

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Health Condition or Problem studied

ICD10: C25 - Malignant neoplasm of pancreas

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Interventions/Observational Groups

Arm 1: Intraoperative general anesthesia and postoperative patient-controlled intravenous analgesia (IV-PCA).
Arm 2: Combined intraoperative general and epidural anesthesia and postoperative epidural analgesia (EDA).

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Active control (effective treament of control group)
Purpose: Treatment
Assignment: Parallel
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

Combined endpoint of gastrointestinal complications (Delayed gastric emptying, pancreatic fistula, biliary leak, gastrointestinal bleeding, postoperative ileus) until postoperative day 30.

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Secondary Outcome

- Delayed gastric emptying
- Pancreatic fistula
- Biliary leak
- Gastrointestinal bleeding
- Postoperative ileus
- Combined endpoint of infectious complications (pneumonia, urinary tract infection, wound infection intraabdominal abscess, sepsis)
- Hospital stay / ICU stay / readmission until postoperative day 30
- Mortality
- Morbidity until postoperative day 30
- Frequency of blood transfusions
- Amount of given vasopressors during operation
- Pain control with numeric rating scale (NRS)
- Amount of given fluids
- Weight over time/weight changes
- SAE

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Countries of Recruitment

DE: Germany
IT: Italy
UK: United Kingdom
SI: Slovenia

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Locations of Recruitment

University Medical Center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie , Heidelberg
University Medical Center Klinik & Poliklinik für Allgemein- und Viszeralchirurgie, Gefäß- und Kinderchirurgie, Würzburg
Medical Center Klinik für Allgemein-, Viszeral-, Thorax- und Transplantationschirurgie, Stuttgart
University Medical Center Klinik für Allgemeine Chirurgie , Lübeck
University Medical Center Klinik für Allgemein-, Viszeral-, Thorax-, Transplantations- und Kinderchirurgie, Gießen
University Medical Center Chirurgische Klinik, Department für Allgemein- und Viszeralchirurgie, Freiburg im Breisgau

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2015/06/30
Target Sample Size: 370
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

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

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Exclusion Criteria

- Chronic pancreatitis
- Severe COPD (Stage III according to GOLD criteria)
- American Society of Anesthesiologists (ASA) physical status classification ≥ IV
- Patients with chronic pain syndrome due to any reason
- Presence of contraindication(s) to the use of patient-controlled intravenous analgesia or epidural analgesia
- Participation in another intervention-trial with interference of intervention and outcome of this study
- Language problems

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Addresses

Primary Sponsor
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- Universitätsklinikum Heidelberg
- Im Neuenheimer Feld 672
- 69120 Heidelberg
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.klinikum.uni-heidelberg.de
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Contact for Scientific Queries
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- Abteilung für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik Heidelberg 69120 Heidelberg Germany
- Mr. Dr. med. Phillip Knebel
- Im Neuenheimer Feld 110
- 69120 Heidelberg
- Germany
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- Telephone: 06221-56-6986
- Fax: 06221-56-6988
- E-mail: phillip.knebel at med.uni-heidelberg.de
- URL: http://www.klinikum.uni-heidelberg.de/Chirurgische-Klinik.1010.0.html
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Contact for Public Queries
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- Abteilung für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik Heidelberg 69120 Heidelberg Germany
- Mr. Dr. med. Phillip Knebel
- Im Neuenheimer Feld 110
- 69120 Heidelberg
- Germany
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- Telephone: 06221-56-6986
- Fax: 06221-56-6988
- E-mail: phillip.knebel at med.uni-heidelberg.de
- URL: http://www.klinikum.uni-heidelberg.de/Chirurgische-Klinik.1010.0.html
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Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)
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- Förderrichtlinien Geförderte Projekte Metropolregion Rhein-NeckarDietmar Hopp Stiftung gGmbH
- Raiffeisenstraße 51
- 68789 St. Leon-Rot
- Germany
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- Telephone: +49(0)6227 8608550
- Fax: +49(0)6227 8608571
- E-mail: info at dietmar-hopp-stiftung.de
- URL: http://dietmar-hopp-stiftung.de
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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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.