Pylorus‐preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma

Markus K Diener; Christina Fitzmaurice; Guido Schwarzer; Christoph M Seiler; Felix J Hüttner; Gerd Antes; Hanns‐Peter Knaebel; Markus W Büchler

doi:10.1002/14651858.CD006053.pub5

Cochrane Database of Systematic Reviews

Pylorus‐preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma

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DOI:

https://doi.org/10.1002/14651858.CD006053.pub5 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

11 noviembre 2014see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Salud digestiva

Copyright:

Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Markus K Diener

Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany
Christina Fitzmaurice

Hematology‐Oncology, University of Washington/Fred Hutchinson Cancer Research Center, Seattle, USA
Guido Schwarzer

Center for Medical Biometry and Medical Informatics, Medical Center ‐ University of Freiburg, Freiburg, Germany
Christoph M Seiler

Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany
Felix J Hüttner

Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany
Gerd Antes

German Cochrane Centre, University Medical Center Freiburg, Freiburg, Germany
Hanns‐Peter Knaebel

Clinical Science, Business Development, Biosurgicals, AESCULAP AG, Tuttlingen, Germany
Markus W Büchler

Correspondencia a: Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany

[email protected]

Contributions of authors

Markus Diener and Christina Fitzmaurice contributed equally to this work.

MKD
Designing the review.
Collecting data for the review.
Undertaking searches.
Screening search results.
Organising retrieval of papers.
Screening retrieved papers against inclusion criteria.
Appraising quality of papers.
Extracting data from papers.
Writing to authors of papers to ask for additional information.
Providing additional data about papers.
Obtaining and screening data on unpublished studies.
Managing data for the review.
Entering data into RevMan.
Analysing data.
Interpreting data.
Providing a methodological perspective.
Providing a clinical perspective.
Providing a consumer perspective.
Writing the review.
Performing previous work that served as the foundation of the current study.

CF
Collecting data for the review.
Designing search strategies.
Undertaking searches.
Screening search results.
Organising retrieval of papers.
Screening retrieved papers against inclusion criteria.
Appraising quality of papers.
Extracting data from papers.
Writing to authors of papers to ask for additional information.
Providing additional data about papers.
Obtaining and screening data on unpublished studies.
Managing data for the review.
Entering data into RevMan.
Analysing data.
Interpreting data.
Writing the review.
Revising the review after peer review.

GS
Extracting data from papers.
Analysing data.
Interpreting data.

CMS
Providing a methodological perspective.
Providing general advice on the review.
Interpreting the data.
Providing a clinical perspective.
Providing a policy perspective.

FH
Screening search results.
Organising retrieval of papers.
Screening retrieved papers against inclusion criteria.
Providing a clinical perspective.
Updating the review.

GA
Providing a methodological perspective.
Providing general advice on the review.

MWB
Providing a clinical perspective.
Providing a policy perspective.
Providing general advice on the review.

HPK
Conceiving of the review.
Co‐ordinating the review.
Interpreting the data.
Providing general advice on the review.
Providing a clinical perspective.
Providing a policy perspective.

Declarations of interest

MKD: none known.

CF: holds a T32 NIH training grant (United States of America).

GS: none known.

CS: none known.

FH: none known.

GA: none known.

HPK: After the publication of the first version of this review, Hanns‐Peter Knaebel became the Chief Executive Officer of Aesculap AG (a medical device company which produces surgical instruments) and as such is now in breach of Cochrane's commercial sponsorship policy. As the conclusions of the review have not changed since it was first conducted, the review has not been withdrawn. Hanns‐Peter Knaebel will not be an author of future versions of this review while he is employed by Aesculap AG.

MB: none known.

Acknowledgements

This review was carried out on the basis of a systematic review and meta‐analysis published elsewhere (Diener 2007).

Christina Fitzmaurice holds a T32 NIH training grant (United States of America).

Version history

Published

Title

Stage

Authors

Version

2016 Feb 16

Pylorus‐preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma

Review

Felix J Hüttner, Christina Fitzmaurice, Guido Schwarzer, Christoph M Seiler, Gerd Antes, Markus W Büchler, Markus K Diener

https://doi.org/10.1002/14651858.CD006053.pub6

2014 Nov 11

Pylorus‐preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma

Review

Markus K Diener, Christina Fitzmaurice, Guido Schwarzer, Christoph M Seiler, Felix J Hüttner, Gerd Antes, Hanns‐Peter Knaebel, Markus W Büchler

https://doi.org/10.1002/14651858.CD006053.pub5

2011 May 11

Pylorus‐preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma

Review

Markus K Diener, Christina Fitzmaurice, Guido Schwarzer, Christoph M Seiler, Gerd Antes, Hanns‐Peter Knaebel, Markus W Büchler

https://doi.org/10.1002/14651858.CD006053.pub4

2011 Feb 16

Pancreaticoduodenectomy (classic Whipple) versus pylorus‐preserving pancreaticoduodenectomy (pp Whipple) for surgical treatment of periampullary and pancreatic carcinoma

Review

Markus K Diener, Christina Heukaeufer, Guido Schwarzer, Christoph M Seiler, Gerd Antes, Hanns‐Peter Knaebel, Markus W Büchler

https://doi.org/10.1002/14651858.CD006053.pub3

2008 Apr 23

Pancreaticoduodenectomy (classic Whipple) versus pylorus‐preserving pancreaticoduodenectomy (pp Whipple) for surgical treatment of periampullary and pancreatic carcinoma

Review

Markus K Diener, Christina Heukaeufer, Guido Schwarzer, Christoph M Seiler, Gerd Antes, Hanns‐Peter Knaebel, Markus W Büchler

https://doi.org/10.1002/14651858.CD006053.pub2

2006 Apr 19

Pancreaticoduodenectomy (classical Whipple) versus pylorus‐preserving pancreaticoduodenectomy (pp Whipple) for surgical treatment of periampullary and pancreatic carcinoma

Protocol

Markus Diener, C Heukaufer, Christoph M Seiler, Gerd Antes, Markus W Büchler, Hanns‐Peter Knaebel, C Heukaeufer

https://doi.org/10.1002/14651858.CD006053

Differences between protocol and review

The review differs in five points from the previously published protocol.

We summarised the outcomes of postoperative bleeding and postoperative gastrointestinal bleeding into a single outcome.
We discarded the outcomes of intra‐abdominal fluid collection/abscess, duration of intensive care unit stay, early and late dumping, postoperative reflux, number and status of removed lymph nodes, shock, sepsis, renal failure, weight loss and endocrine and exocrine insufficiency because no usable data were available.
We performed an additional quality assessment on the basis of a checklist developed by Downs et al (Downs 1998).
We performed a subgroup analysis for pancreatic head cancer and periampullary cancer for survival.
We performed a sensitivity analysis for DGE by using different definitions.

Notes

Christina Fitzmaurice and Markus Diener are joint first review authors and have contributed equally to this work.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Female; Humans; Male;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Study flow diagram.

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Figure 4

Funnel plot of comparison: 1 Survival, outcome: 1.1 Overall.

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Figure 5

Funnel plot of comparison: 2 Mortality, outcome: 2.1 Postoperative mortality.

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Figure 6

Funnel plot of comparison: 3 Pancreatic fistula, outcome: 3.1 Pancreatic fistula.

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Analysis 1.1

Comparison 1 Survival, Outcome 1 Overall.

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Analysis 1.2

Comparison 1 Survival, Outcome 2 Pancreatic head carcinoma.

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Analysis 1.3

Comparison 1 Survival, Outcome 3 Periampullary cancer.

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Analysis 2.1

Comparison 2 Mortality, Outcome 1 Postoperative mortality.

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Analysis 3.1

Comparison 3 Pancreatic fistula, Outcome 1 Pancreatic fistula.

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Analysis 4.1

Comparison 4 Delayed gastric emptying (with sensitivity analysis), Outcome 1 All studies.

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Analysis 4.2

Comparison 4 Delayed gastric emptying (with sensitivity analysis), Outcome 2 Studies in which DGE was defined (includes different definitions).

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Analysis 4.3

Comparison 4 Delayed gastric emptying (with sensitivity analysis), Outcome 3 Studies with the same definitions of DGE.

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Analysis 5.1

Comparison 5 Biliary leakage, Outcome 1 Biliary leakage.

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Analysis 6.1

Comparison 6 Intraoperative blood loss, Outcome 1 Intraoperative blood loss (litres).

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Analysis 7.1

Comparison 7 Red blood cell transfusion, Outcome 1 Red blood cell transfusion.

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Analysis 8.1

Comparison 8 Operating time, Outcome 1 Operating time (minutes).

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Analysis 9.1

Comparison 9 Postoperative bleeding, Outcome 1 Postoperative bleeding.

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Analysis 10.1

Comparison 10 Wound infection, Outcome 1 Wound infection.

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Analysis 11.1

Comparison 11 Pulmonary complications, Outcome 1 Pulmonary complications.

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Analysis 12.1

Comparison 12 Necessity for reoperation, Outcome 1 Necessity for reoperation.

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Analysis 13.1

Comparison 13 Hospital stay, Outcome 1 Hospital stay (days).

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Summary of findings for the main comparison. Survival after surgical treatment for periampullary or pancreatic carcinoma

Survival after surgical treatment for periampullary or pancreatic carcinoma
Patient or population: patients with surgical treatment of periampullary or pancreatic carcinoma Settings: Intervention: survival
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Survival
Overall survival Follow‐up: 18 to 144 months	Medium‐risk population		HR 0.84 (0.61 to 1.16)	0 (3 studies)	⊕⊕⊝⊝ low^a,b

The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; HR: Hazard ratio.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aInadequate information about sequence generation and allocation concealment. No intention‐to‐treat analysis. ^bVery wide confidence intervals, unknown number of losses to follow‐up, low total number of events, no sample size calculations reported.

Summary of findings for the main comparison. Survival after surgical treatment for periampullary or pancreatic carcinoma

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Summary of findings 2. Mortality after surgical treatment for periampullary or pancreatic carcinoma

Mortality after surgical treatment for periampullary or pancreatic carcinoma
Patient or population: patients with surgical treatment for periampullary and pancreatic carcinoma Settings: Intervention: mortality
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Mortality
Postoperative mortality	Study population		OR 0.49 (0.17 to 1.4)	417 (5 studies)	⊕⊕⊝⊝ low^a,b
	52 per 1000	26 per 1000 (9 to 71)
	Medium‐risk population
	44 per 1000	22 per 1000 (8 to 61)
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aConfidence intervals are wide because of small number of events. No sample size calculation was reported for trials except for Seiler and Tran. ^bPublication bias is unlikely but cannot be excluded. Funnel plotting did not reveal vast asymmetry. However, publication bias cannot be quantified because of the small number of available trials.

Summary of findings 2. Mortality after surgical treatment for periampullary or pancreatic carcinoma

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Summary of findings 3. Intraoperative blood loss in surgical treatment of patients with periampullary or pancreatic carcinoma

Intraoperative blood loss in surgical treatment of patients with periampullary or pancreatic carcinoma
Patient or population: patients with surgical treatment for periampullary or pancreatic carcinoma Settings: Intervention: intraoperative blood loss
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Intraoperative blood loss
Intraoperative blood loss (litres)		Mean intraoperative blood loss (litres) in the intervention groups was 0.76 lower (0.96 to 0.56 lower)		33 (1 study)	⊕⊕⊝⊝ low^a,b
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aSmall number of participants. ^bPublication bias is unlikely but cannot be excluded. Funnel plotting did not reveal vast asymmetry. However, publication bias cannot be quantified because of the small number of available trials.

Summary of findings 3. Intraoperative blood loss in surgical treatment of patients with periampullary or pancreatic carcinoma

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Summary of findings 4. Operating time in surgical treatment for periampullary or pancreatic carcinoma

Operating time in surgical treatment for periampullary or pancreatic carcinoma
Patient or population: patients with surgical treatment for periampullary and pancreatic carcinoma Settings: Intervention: operating time
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Operating time
Operating time (minutes)		Mean operating time (minutes) in the intervention groups was 68.26 lower (105.7 to 30.83 lower)		125 (3 studies)	⊕⊕⊝⊝ low^a,b,c
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aSerious limitations in the study design in the trials of Bloechle, Lin and Wenger are a potential source of bias. All are characterised by small sample sizes, lack of blinding and incomplete outcome reporting. ^bWide confidence intervals indicate significant imprecision of this pooled outcome variable, which causes potential bias. This imbalance in operating time across included trials might be caused by the overall small sample sizes or by unstandardised assessment. ^cPublication bias is unlikely but cannot be excluded. Funnel plotting did not reveal vast asymmetry. However, publication bias cannot be quantified because of the small number of available trials.

Summary of findings 4. Operating time in surgical treatment for periampullary or pancreatic carcinoma

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Comparison 1. Survival

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall Show forest plot	3		Hazard ratio (Random, 95% CI)	0.84 [0.61, 1.16]

2 Pancreatic head carcinoma Show forest plot	3		Hazard ratio (Random, 95% CI)	0.73 [0.43, 1.22]

3 Periampullary cancer Show forest plot	2		Hazard ratio (Random, 95% CI)	0.83 [0.39, 1.76]

Comparison 1. Survival

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Comparison 2. Mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative mortality Show forest plot	5	417	Odds Ratio (M‐H, Random, 95% CI)	0.49 [0.17, 1.40]

Comparison 2. Mortality

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Comparison 3. Pancreatic fistula

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pancreatic fistula Show forest plot	5	421	Odds Ratio (M‐H, Random, 95% CI)	0.86 [0.41, 1.81]

Comparison 3. Pancreatic fistula

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Comparison 4. Delayed gastric emptying (with sensitivity analysis)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All studies Show forest plot	5	412	Odds Ratio (M‐H, Random, 95% CI)	2.35 [0.72, 7.61]

2 Studies in which DGE was defined (includes different definitions) Show forest plot	3	328	Odds Ratio (M‐H, Random, 95% CI)	1.14 [0.35, 3.68]

3 Studies with the same definitions of DGE Show forest plot	2	198	Odds Ratio (M‐H, Random, 95% CI)	4.02 [0.14, 119.16]

Comparison 4. Delayed gastric emptying (with sensitivity analysis)

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Comparison 5. Biliary leakage

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Biliary leakage Show forest plot	3	333	Odds Ratio (M‐H, Random, 95% CI)	1.35 [0.10, 18.55]

Comparison 5. Biliary leakage

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Comparison 6. Intraoperative blood loss

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intraoperative blood loss (litres) Show forest plot	1	33	Mean Difference (IV, Random, 95% CI)	‐0.76 [‐0.96, ‐0.56]

Comparison 6. Intraoperative blood loss

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Comparison 7. Red blood cell transfusion

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Red blood cell transfusion Show forest plot	2	79	Mean Difference (IV, Random, 95% CI)	‐0.65 [‐1.92, 0.61]

Comparison 7. Red blood cell transfusion

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Comparison 8. Operating time

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Operating time (minutes) Show forest plot	3	125	Mean Difference (IV, Random, 95% CI)	‐68.26 [‐105.70, ‐30.83]

Comparison 8. Operating time

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Comparison 9. Postoperative bleeding

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative bleeding Show forest plot	3	333	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.29, 1.88]

Comparison 9. Postoperative bleeding

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Comparison 10. Wound infection

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Wound infection Show forest plot	4	251	Odds Ratio (M‐H, Random, 95% CI)	0.85 [0.35, 2.05]

Comparison 10. Wound infection

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Comparison 11. Pulmonary complications

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pulmonary complications Show forest plot	3	218	Odds Ratio (M‐H, Random, 95% CI)	0.67 [0.29, 1.58]

Comparison 11. Pulmonary complications

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Comparison 12. Necessity for reoperation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Necessity for reoperation Show forest plot	2	300	Odds Ratio (M‐H, Random, 95% CI)	0.82 [0.38, 1.75]

Comparison 12. Necessity for reoperation

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Comparison 13. Hospital stay

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Hospital stay (days) Show forest plot	1	48	Mean Difference (IV, Random, 95% CI)	‐1.80 [‐8.94, 5.34]

Comparison 13. Hospital stay

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Pylorus‐preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma

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Medical Subject Headings Check Words

PICO

PICO

Population

Intervention

Comparison

Outcome

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