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

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

doi:10.1002/14651858.CD006053.pub6

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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 Postoperative 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 Pancreatic fistula, Outcome 1 Pancreatic fistula.

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Analysis 2.1

Comparison 2 Delayed gastric emptying (with sensitivity analysis), Outcome 1 All studies.

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Analysis 2.2

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

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Analysis 2.3

Comparison 2 Delayed gastric emptying (with sensitivity analysis), Outcome 3 Studies with the same definitions of DGE.

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Analysis 3.1

Comparison 3 Biliary leakage, Outcome 1 Biliary leakage.

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Analysis 4.1

Comparison 4 Survival, Outcome 1 Overall.

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Analysis 4.2

Comparison 4 Survival, Outcome 2 Pancreatic head carcinoma.

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Analysis 4.3

Comparison 4 Survival, Outcome 3 Periampullary cancer.

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Analysis 5.1

Comparison 5 Postoperative mortality, Outcome 1 Postoperative mortality.

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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 Duration of hospital stay, Outcome 1 Hospital stay (days).

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Analysis 14.1

Comparison 14 R0 resection rate, Outcome 1 R0 resection rate.

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Summary of findings for the main comparison. Postoperative mortality and DGE after surgical treatment for periampullary or pancreatic carcinoma

Postoperative mortality and DGE after surgical treatment for periampullary or pancreatic carcinoma
Patient or population: people with surgical treatment for periampullary or pancreatic carcinoma Settings: surgical departments in Asia and Europe Intervention: PPW Comparison: CW
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	CW	PPW
Postoperative mortality	60 per 1000	39 per 1000 (16 to 89)	OR 0.64 (0.26 to 1.54)	464 (7 trials)	⊕⊕⊕⊝ moderate^a
Pancreatic fistula	93 per 1000	88 per 1000 (48 to 158)	OR 0.95 (0.49 to 1.84)	468 (7 trials)	⊕⊕⊝⊝ low^a,b
DGE	235 per 1000	482 per 1000 (244 to 728)	OR 3.03 (1.05 to 8.70)	459 (7 trials)	⊕⊕⊝⊝ low^a,b
The basis for the assumed risk* was the mean risk in the control group across studies. 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; CW: classic Whipple; DGE: delayed gastric emptying; OR: odds ratio; PPW: pylorus‐preserving Whipple
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 due to small number of events. No sample size calculation was reported for trials except for Seiler 2005 and Tran 2004. ^bStrong heterogeneity due to differing outcome definitions and clinical heterogeneity between trials.

Summary of findings for the main comparison. Postoperative mortality and DGE after surgical treatment for periampullary or pancreatic carcinoma

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

Survival after surgical treatment for periampullary or pancreatic carcinoma
Patient or population: people with surgical treatment for periampullary or pancreatic carcinoma Settings: surgical departments in Asia and Europe Intervention: PPW Comparison: CW
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	CW	PPW
Overall survival Follow‐up: 18 to 144 months	Medium‐risk population		HR 0.84 (0.61 to 1.16)	284 (3 trials)	⊕⊕⊝⊝ 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; CW: classic Whipple; HR: hazard ratio; PPW: pylorus‐preserving Whipple
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 2. Survival after surgical treatment for periampullary or pancreatic carcinoma

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Summary of findings 3. Operating time, intraoperative blood loss, and red blood cell transfusion in surgical treatment for periampullary or pancreatic carcinoma

Operating time, intraoperative blood loss, and red blood cell transfusion in surgical treatment for periampullary or pancreatic carcinoma
Patient or population: people with surgical treatment for periampullary or pancreatic carcinoma Settings: surgical departments in Asia and Europe Intervention: PPW Comparison: CW
Outcomes	Illustrative comparative risks (95% CI)	Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	CW vs PPW
Intraoperative blood loss (millilitres)	Mean intraoperative blood loss in the intervention group was 320 millilitres lower than in the control group (620 to 30 lower)	MD ‐0.32 (‐0.62 to ‐0.03)	404 (5 trials)	⊕⊕⊝⊝ low^a,b,c
Red blood cell transfusion (units)	Mean red blood cell transfusion in the intervention group was 0.47 units lower than in the control group (0.86 to 0.07 lower)	MD ‐0.47 (‐0.86 to ‐0.07)	273 (5 trials)	⊕⊕⊝⊝ low^a,b
Operating time (minutes)	Mean operating time in the intervention group was 45 minutes lower than in the control group (75 to 16 lower)	MD ‐45.22 (‐74.67 to ‐15.78)	472 (7 trials)	⊕⊕⊝⊝ low^a,b,c
CI: confidence interval; CW: classic Whipple; MD: mean difference; PPW: pylorus‐preserving Whipple
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 of Bloechle 1999, Lin 1999, Taher 2015, and Wenger 1999 are a potential source of bias. All are characterised by small sample sizes, lack of blinding, and incomplete outcome reporting. ^bThe distribution of these continuous outcomes is known to be potentially skewed, which introduces a potential bias in the analyses. ^cStrong heterogeneity in the analyses.

Summary of findings 3. Operating time, intraoperative blood loss, and red blood cell transfusion in surgical treatment for periampullary or pancreatic carcinoma

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Comparison 1. Pancreatic fistula

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pancreatic fistula Show forest plot	7	468	Odds Ratio (M‐H, Random, 95% CI)	0.95 [0.49, 1.84]

Comparison 1. Pancreatic fistula

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Comparison 2. 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	7	459	Odds Ratio (M‐H, Random, 95% CI)	3.03 [1.05, 8.70]

2 Studies in which DGE was defined (includes different definitions) Show forest plot	4	355	Odds Ratio (M‐H, Random, 95% CI)	2.00 [0.55, 7.22]

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 2. Delayed gastric emptying (with sensitivity analysis)

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Comparison 3. Biliary leakage

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Biliary leakage Show forest plot	5	380	Odds Ratio (M‐H, Random, 95% CI)	0.96 [0.15, 6.17]

Comparison 3. Biliary leakage

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Comparison 4. Survival

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall Show forest plot	3	284	Hazard ratio (Random, 95% CI)	0.84 [0.61, 1.16]

2 Pancreatic head carcinoma Show forest plot	3	203	Hazard ratio (Random, 95% CI)	0.73 [0.43, 1.22]

3 Periampullary cancer Show forest plot	2	74	Hazard ratio (Random, 95% CI)	0.83 [0.39, 1.76]

Comparison 4. Survival

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Comparison 5. Postoperative mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative mortality Show forest plot	7	464	Odds Ratio (M‐H, Random, 95% CI)	0.64 [0.26, 1.54]

Comparison 5. Postoperative mortality

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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	5	404	Mean Difference (IV, Random, 95% CI)	‐0.32 [‐0.62, ‐0.03]

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	5	273	Mean Difference (IV, Random, 95% CI)	‐0.47 [‐0.86, ‐0.07]

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	7	472	Mean Difference (IV, Random, 95% CI)	‐45.22 [‐74.67, ‐15.78]

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	5	380	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.32, 1.74]

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	3	320	Odds Ratio (M‐H, Random, 95% CI)	0.80 [0.38, 1.68]

Comparison 12. Necessity for reoperation

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Comparison 13. Duration of hospital stay

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Hospital stay (days) Show forest plot	5	366	Mean Difference (IV, Random, 95% CI)	0.26 [‐2.04, 2.56]

Comparison 13. Duration of hospital stay

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Comparison 14. R0 resection rate

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 R0 resection rate Show forest plot	4	359	Odds Ratio (M‐H, Random, 95% CI)	0.92 [0.39, 2.15]

Comparison 14. R0 resection rate

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