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

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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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