ID

45592

Beskrivning

Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head. Study Center of the German Surgical Society (SDGC) Trial protocol of a randomised controlled multicentre trial. Trials. 2010 Apr 29;11:47. doi: 10.1186/1745-6215-11-47. PMID: 20429912; PMCID: PMC2874785. Controlled-trials.com ISRCTN38973832

Länk

Publication

Nyckelord

Versioner (1)
  1. 2023-02-06 2023-02-06 - Dr. Christian Niklas
Rättsinnehavare

Diener MK, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt HJ, Mössner J, Kieser M, Werner J, Büchler MW, Seiler CM

Uppladdad den

6 februari 2023

DOI

10.1186/1745-6215-11-47

Licens

Creative Commons BY 4.0
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ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis

Engelsk

Start Questionnaire

7 Formulär  
  1. StudyEvent: Visit 1 : Screening
    1. Start Questionnaire
  2. StudyEvent: Visit 2 : Operation
    1. Start Questionnaire
  3. StudyEvent: Visit 3: Discharge
    1. Start Questionnaire
  4. StudyEvent: Visit 4: 6 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  5. StudyEvent: Visit 5: 12 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  6. StudyEvent: Visit 6: 24 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  7. StudyEvent: End of Study
    1. Start Questionnaire
Date of Visit
Beskrivning

Date of Visit

Alias
UMLS CUI [1,1]
C1320303
please enter the date of the first visit
Beskrivning

Date of first Visit

Datatyp

date

Alias
UMLS CUI [1,1]
C1320303
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI [1,1]
C1512693
Patient is scheduled for primary surgery for chronic headpancreatitis
Beskrivning

scheduled for primary surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3242215
Ability to understand character and individual consequences of the clinical trial
Beskrivning

Ability to understand

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
Written informed consent
Beskrivning

Written consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0742766
Date of written informed consent:
Beskrivning

Date of consent

Datatyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI [1,1]
C0680251
Participation in another intervention-trial with interference of intervention and outcome of this study
Beskrivning

Participation in another intervention-trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521115
UMLS CUI [1,3]
C0814861
Quality of Life
Beskrivning

Quality of Life

Alias
UMLS CUI [1,1]
C0034380
EORTC QLQ-C30 form completed
Beskrivning

QLQ-C30 form

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3476431
EORTC QLQ-PAN26 form completed
Beskrivning

QLQ-PAN26

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3476431
Demography
Beskrivning

Demography

Alias
UMLS CUI [1,1]
C0011298
Gender
Beskrivning

Gender

Datatyp

integer

Alias
UMLS CUI [1,1]
C0079399
Age
Beskrivning

Age

Datatyp

integer

Måttenheter
  • year
Alias
UMLS CUI [1,1]
C0001779
year
Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1,1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

integer

Måttenheter
  • kg
Alias
UMLS CUI [1,1]
C0005910
kg
Baseline Clinical Data
Beskrivning

Baseline Clinical Data

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C1516606
Smoking History
Beskrivning

Smoking History

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519384
cigarettes per day
Beskrivning

cigarettes per day

Datatyp

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
number of years
Beskrivning

years smoking

Datatyp

integer

Alias
UMLS CUI [2,1]
C1265611
UMLS CUI [2,2]
C0439234
UMLS CUI [2,3]
C0543414
stopped in year
Beskrivning

stopped in year

Datatyp

date

Alias
UMLS CUI [1,1]
C0425310
UMLS CUI [1,2]
C0439234
Alcohol Consumption
Beskrivning

Alcohol Consumption

Datatyp

integer

Alias
UMLS CUI [1,1]
C0001948
stopped in year
Beskrivning

stopped in year

Datatyp

integer

Alias
UMLS CUI [1,1]
C0425321
UMLS CUI [1,2]
C0439234
please specify
Beskrivning

specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0001948
Duration of Chronic Pancreatitis Related Symptoms
Beskrivning

Duration of Chronic Pancreatitis Related Symptoms

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0149521
Pain
Beskrivning

Pain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
please specify duration
Beskrivning

duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439231
months
Indigestion
Beskrivning

Indigestion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013395
please specify duration
Beskrivning

duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439231
UMLS CUI [1,3]
C0013395
months
Weight loss
Beskrivning

Weight loss

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1262477
please specify duration
Beskrivning

duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439231
UMLS CUI [1,3]
C1262477
months
weight loss
Beskrivning

weight loss

Datatyp

integer

Måttenheter
  • kg
Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439209
kg
Diabetes Mellitus (under current oral or s.c. medication)
Beskrivning

Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0013216
please specify duration
Beskrivning

duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439231
UMLS CUI [1,3]
C0011849
months
Exocrine insufficiency (continuous supplement of enzymes necessary)
Beskrivning

Exocrine insufficiency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0267963
UMLS CUI [1,2]
C0948571
please specify duration
Beskrivning

duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439231
UMLS CUI [1,3]
C0267963
UMLS CUI [1,4]
C0948571
months
Imaging Techniques
Beskrivning

Imaging Techniques

Alias
UMLS CUI [1,1]
C0011923
Patient had CT
Beskrivning

CT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040405
Patient had MRT
Beskrivning

MRT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
Results of preoperative imaging studies
Beskrivning

Results of preoperative imaging studies

Alias
UMLS CUI [1,1]
C0445204
UMLS CUI [1,2]
C1881134
UMLS CUI [1,3]
C1274040
Pancreatic head enlargement
Beskrivning

Pancreatic head enlargement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3149699
Presence of calcification in the pancreas
Beskrivning

pancreas calcification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0747173
Enlargement of the common bile duct
Beskrivning

Enlargement common bile duct

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020564
UMLS CUI [1,2]
C0009437
Enlargement of the pancreatic duct
Beskrivning

Enlargement of the pancreatic duct

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020564
UMLS CUI [1,2]
C0030288
Compression of retropancreatic vessels
Beskrivning

Compression retropancreatic vessels

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0227594
UMLS CUI [1,2]
C3160813
Results of Preoperative Endoscopy
Beskrivning

Results of Preoperative Endoscopy

Alias
UMLS CUI [1,1]
C0445204
UMLS CUI [1,2]
C0014245
UMLS CUI [1,3]
C1274040
Duodenal obstruction
Beskrivning

Duodenal obstruction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013292
Frequency of ERCP (Endoscopic Retrograde Cholangio Pancreaticography)
Beskrivning

Frequency of ERCP (Endoscopic Retrograde Cholangio Pancreaticography)

Alias
UMLS CUI [1,1]
C1561548
UMLS CUI [1,2]
C0008310
Frequency of ERCP
Beskrivning

Frequency of ERCP

Datatyp

string

Alias
UMLS CUI [1,1]
C1561548
UMLS CUI [1,2]
C0008310
Number of pancreatic stent implantation
Beskrivning

number pancreatic stents

Datatyp

integer

Alias
UMLS CUI [1,1]
C0183516
UMLS CUI [1,2]
C0449958
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Similar models

Start Questionnaire

7 Formulär
  1. StudyEvent: Visit 1 : Screening
    1. Start Questionnaire
  2. StudyEvent: Visit 2 : Operation
    1. Start Questionnaire
  3. StudyEvent: Visit 3: Discharge
    1. Start Questionnaire
  4. StudyEvent: Visit 4: 6 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  5. StudyEvent: Visit 5: 12 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  6. StudyEvent: Visit 6: 24 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  7. StudyEvent: End of Study
    1. Start Questionnaire
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI [1,1])
Date of first Visit
Item
please enter the date of the first visit
date
C1320303 (UMLS CUI [1,1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI [1,1])
scheduled for primary surgery
Item
Patient is scheduled for primary surgery for chronic headpancreatitis
boolean
C3242215 (UMLS CUI [1,1])
Ability to understand
Item
Ability to understand character and individual consequences of the clinical trial
boolean
C0021430 (UMLS CUI [1,1])
Written consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0742766 (UMLS CUI [1,2])
Date of consent
Item
Date of written informed consent:
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI [1,1])
Participation in another intervention-trial
Item
Participation in another intervention-trial with interference of intervention and outcome of this study
boolean
C2348568 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0814861 (UMLS CUI [1,3])
Item Group
Quality of Life
C0034380 (UMLS CUI [1,1])
QLQ-C30 form
Item
EORTC QLQ-C30 form completed
boolean
C3476431 (UMLS CUI [1,1])
QLQ-PAN26
Item
EORTC QLQ-PAN26 form completed
boolean
C3476431 (UMLS CUI [1,1])
Item Group
Demography
C0011298 (UMLS CUI [1,1])
Item
Gender
integer
C0079399 (UMLS CUI [1,1])
CL.1
Code List
Gender
CL Item
male (0)
C0086582 (UMLS CUI [1,1])
CL Item
female (1)
C0086287 (UMLS CUI [1,1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1,1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1,1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1,1])
Item Group
Baseline Clinical Data
C1442488 (UMLS CUI [1,1])
C1516606 (UMLS CUI [1,2])
Item
Smoking History
integer
C1519384 (UMLS CUI [1,1])
CL.2
Code List
Smoking History
CL Item
Non-smoker (0)
C0337672 (UMLS CUI [1,1])
CL Item
Current smoker (1)
C3241966 (UMLS CUI [1,1])
CL Item
Previous-smoker (2)
C0337671 (UMLS CUI [1,1])
cigarettes per day
Item
cigarettes per day
integer
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
years smoking
Item
number of years
integer
C1265611 (UMLS CUI [2,1])
C0439234 (UMLS CUI [2,2])
C0543414 (UMLS CUI [2,3])
stopped in year
Item
stopped in year
date
C0425310 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Item
Alcohol Consumption
integer
C0001948 (UMLS CUI [1,1])
CL.3
Code List
Alcohol Consumption
CL Item
never (0)
C2136009 (UMLS CUI [1,1])
CL Item
current consumption (1)
C0001948 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
CL Item
previous consumption (2)
C4745093 (UMLS CUI [1,1])
stopped in year
Item
stopped in year
integer
C0425321 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Item
please specify
integer
C1521902 (UMLS CUI [1,1])
C0001948 (UMLS CUI [1,2])
CL.4
Code List
please specify
CL Item
Sporadic: 1 or 2 glasses of wine / beer per day up to 2 drinks per week (0)
C0205422 (UMLS CUI [1,1])
CL Item
Regular: 3 glasses of wine / beer per day or 20 drinks per week, patient is able to stop daily consumption (1)
C0205272 (UMLS CUI [1,1])
CL Item
Excessive: more than 3 glasses of wine / beer per day or more than 20 drinks per week, patient is unable to stop daily consumption (2)
C0442802 (UMLS CUI [1,1])
Item Group
Duration of Chronic Pancreatitis Related Symptoms
C0449238 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0149521 (UMLS CUI [1,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
duration
Item
please specify duration
integer
C0449238 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
Indigestion
Item
Indigestion
boolean
C0013395 (UMLS CUI [1,1])
duration
Item
please specify duration
integer
C0449238 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C0013395 (UMLS CUI [1,3])
Weight loss
Item
Weight loss
boolean
C1262477 (UMLS CUI [1,1])
duration
Item
please specify duration
integer
C0449238 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C1262477 (UMLS CUI [1,3])
weight loss
Item
weight loss
integer
C1262477 (UMLS CUI [1,1])
C0439209 (UMLS CUI [1,2])
Diabetes Mellitus
Item
Diabetes Mellitus (under current oral or s.c. medication)
boolean
C0011849 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
duration
Item
please specify duration
integer
C0449238 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Exocrine insufficiency
Item
Exocrine insufficiency (continuous supplement of enzymes necessary)
boolean
C0267963 (UMLS CUI [1,1])
C0948571 (UMLS CUI [1,2])
duration
Item
please specify duration
integer
C0449238 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C0267963 (UMLS CUI [1,3])
C0948571 (UMLS CUI [1,4])
Item Group
Imaging Techniques
C0011923 (UMLS CUI [1,1])
CT
Item
Patient had CT
boolean
C0040405 (UMLS CUI [1,1])
MRT
Item
Patient had MRT
boolean
C0024485 (UMLS CUI [1,1])
Item Group
Results of preoperative imaging studies
C0445204 (UMLS CUI [1,1])
C1881134 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Pancreatic head enlargement
Item
Pancreatic head enlargement
boolean
C3149699 (UMLS CUI [1,1])
pancreas calcification
Item
Presence of calcification in the pancreas
boolean
C0747173 (UMLS CUI [1,1])
Enlargement common bile duct
Item
Enlargement of the common bile duct
boolean
C0020564 (UMLS CUI [1,1])
C0009437 (UMLS CUI [1,2])
Enlargement of the pancreatic duct
Item
Enlargement of the pancreatic duct
boolean
C0020564 (UMLS CUI [1,1])
C0030288 (UMLS CUI [1,2])
Compression retropancreatic vessels
Item
Compression of retropancreatic vessels
boolean
C0227594 (UMLS CUI [1,1])
C3160813 (UMLS CUI [1,2])
Item Group
Results of Preoperative Endoscopy
C0445204 (UMLS CUI [1,1])
C0014245 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Duodenal obstruction
Item
Duodenal obstruction
boolean
C0013292 (UMLS CUI [1,1])
Item Group
Frequency of ERCP (Endoscopic Retrograde Cholangio Pancreaticography)
C1561548 (UMLS CUI [1,1])
C0008310 (UMLS CUI [1,2])
Frequency of ERCP
Item
Frequency of ERCP
string
C1561548 (UMLS CUI [1,1])
C0008310 (UMLS CUI [1,2])
number pancreatic stents
Item
Number of pancreatic stent implantation
integer
C0183516 (UMLS CUI [1,1])
C0449958 (UMLS CUI [1,2])
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