Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery

Junhua Gong; Sirong He<sup>a</sup>; Yao Cheng; Nansheng Cheng; Jianping Gong; Zhong Zeng

doi:10.1002/14651858.CD009621.pub3

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Figure 1

Study flow diagram.

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Figure 2

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 3

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

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Analysis 1.1

Comparison 1 Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy), Outcome 1 Postoperative pancreatic fistula (ISGPF definition).

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Analysis 1.2

Comparison 1 Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy), Outcome 2 Postoperative mortality.

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Analysis 1.3

Comparison 1 Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy), Outcome 3 Overall postoperative morbidity.

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Analysis 1.4

Comparison 1 Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy), Outcome 4 Reoperation rate.

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Analysis 1.5

Comparison 1 Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy), Outcome 5 Length of hospital stay.

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Analysis 2.1

Comparison 2 Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy), Outcome 1 Postoperative pancreatic fistula (ISGPF definition).

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Analysis 2.2

Comparison 2 Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy), Outcome 2 Postoperative mortality.

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Analysis 2.3

Comparison 2 Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy), Outcome 3 Overall postoperative morbidity.

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Analysis 2.4

Comparison 2 Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy), Outcome 4 Reoperation rate.

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Analysis 2.5

Comparison 2 Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy), Outcome 5 Length of hospital stay.

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Analysis 3.1

Comparison 3 Fibrin sealants versus no fibrin sealant (pancreatic duct occlusion after pancreaticoduodenectomy), Outcome 1 Postoperative mortality.

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Analysis 3.2

Comparison 3 Fibrin sealants versus no fibrin sealant (pancreatic duct occlusion after pancreaticoduodenectomy), Outcome 2 Overall postoperative morbidity.

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Analysis 3.3

Comparison 3 Fibrin sealants versus no fibrin sealant (pancreatic duct occlusion after pancreaticoduodenectomy), Outcome 3 Reoperation rate.

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Analysis 3.4

Comparison 3 Fibrin sealants versus no fibrin sealant (pancreatic duct occlusion after pancreaticoduodenectomy), Outcome 4 Length of hospital stay.

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Summary of findings for the main comparison. Application of fibrin sealants to pancreatic stump closure reinforcement for the prevention of postoperative pancreatic fistula following distal pancreatectomy

Application of fibrin sealants to pancreatic stump closure reinforcement for the prevention of postoperative pancreatic fistula following distal pancreatectomy
Patient or population: people undergoing distal pancreatectomy Setting: hospital Intervention: fibrin sealant Comparison: no fibrin sealant
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no fibrin sealants	Risk with fibrin sealants
Postoperative pancreatic fistula (ISGPF definition) Follow up: 30 days	Study population		RR 0.96 (0.68 to 1.35)	755 (4 studies)	⊕⊕⊝⊝ low^1,2,3
	201 per 1000	193 per 1000 (136 to 271)
	Moderate
	203 per 1000	195 per 1000 (138 to 274)
Postoperative mortality	Study population		Peto OR 0.52 (0.05 to 5.03)	804 (6 studies)	⊕⊕⊝⊝ low^2,4
	5 per 1000	3 per 1000 (0 to 25)
	Moderate
	0 per 1000	0 per 1000 (0 to 0)
Overall postoperative morbidity Follow up: 30 days	Study population		RR 1.23 (0.97 to 1.58)	646 (3 studies)	⊕⊕⊝⊝ low^1,2,3
	232 per 1000	285 per 1000 (225 to 367)
	Moderate
	239 per 1000	294 per 1000 (232 to 378)
Reoperation rate Follow up: 30 days	Study population		RR 0.51 (0.15 to 1.71)	376 (2 studies)	⊕⊝⊝⊝ very low^1,2,4
	38 per 1000	20 per 1000 (6 to 65)
	Moderate
	27 per 1000	14 per 1000 (4 to 46)
Serious adverse events	This outcome was not reported in any of the included studies.
Quality of life	This outcome was not reported in any of the included studies.
Cost effectiveness	This outcome was not reported in any of the included studies.
Length of hospital stay (days)	The mean length of hospital stay was 11.4 days	The mean length of hospital stay was 0.32 days higher (1.06 lower to 1.70 higher)	MD 0.32 (‐1.06 to 1.70)	755 (4 studies)	⊕⊕⊕⊝ moderate^1,2
The basis for the assumed risk* (e.g. the 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; RR: Risk ratio; OR: Odds ratio; MD: Mean difference; ISGPF: International Study Group on Pancreatic Fistula
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.
¹ Downgraded one level for serious risk of bias. ² Publication bias could not be assessed because of there being few studies. ³ Downgraded one level for serious imprecision (the confidence interval of risk ratio overlapped 0.75 and 1.25). ⁴ Downgraded two levels for very serious imprecision (very few events, confidence intervals of risk ratios overlapped 0.75 and 1.25).

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Summary of findings 2. Application of fibrin sealants to pancreatic anastomosis reinforcement for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy

Application of fibrin sealants to pancreatic anastomosis reinforcement for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy
Patient or population: people undergoing pancreaticoduodenectomy Setting: hospital Intervention: fibrin sealant Comparison: no fibrin sealant
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no fibrin sealants	Risk with fibrin sealants
Postoperative pancreatic fistula (ISGPF definition) Follow up: 30 days	Study population		RR 0.25 (0.01 to 5.06)	57 (1 study)	⊕⊝⊝⊝ very low^1,2,3
	62 per 1000	16 per 1000 (1 to 316)
	Moderate
	63 per 1000	16 per 1000 (1 to 319)
Postoperative mortality Follow up: 30 days	Study population		Peto OR 0.15 (0 to 7.76)	251 (3 studies)	⊕⊕⊝⊝ low^2,3
	7 per 1000	1 per 1000 (0 to 54)
	Moderate
	0 per 1000	0 per 1000 (0 to 0)
Overall postoperative morbidity Follow up: 30 days	Study population		RR 0.97 (0.65 to 1.45)	181 (2 studies)	⊕⊝⊝⊝ very low^1,2,3
	347 per 1000	337 per 1000 (226 to 503)
	Moderate
	370 per 1000	359 per 1000 (240 to 537)
Reoperation rate Follow up: 30 days	Study population		RR 0.83 (0.33 to 2.11)	181 (2 studies)	⊕⊝⊝⊝ very low^1,2,3
	92 per 1000	76 per 1000 (30 to 194)
	Moderate
	133 per 1000	110 per 1000 (44 to 281)
Serious adverse events	This outcome was not reported in any of the included studies.
Quality of life	This outcome was not reported in any of the included studies.
Cost effectiveness	This outcome was not reported in any of the included studies.
Length of hospital stay (days)	The mean length of hospital stay was 14.8 days	The mean length of hospital stay was 1.58 days lower (3.96 lower to 0.81 higher)	MD −1.58 (‐3.96 to 0.81)	181 (2 studies)	⊕⊕⊝⊝ low^1,3,4
The basis for the assumed risk* (e.g. the 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; RR: Risk ratio; OR: Odds ratio; MD: Mean difference; ISGPF: International Study Group on Pancreatic Fistula
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.
¹ Downgraded one level for serious risk of bias. ² Downgraded two levels for very serious imprecision (small sample size, confidence intervals of risk ratios overlapped 0.75 and 1.25). ³ Publication bias could not be assessed because of there being few studies. ⁴ Downgraded one level for serious imprecision (total population size was less than 400).

Summary of findings 2. Application of fibrin sealants to pancreatic anastomosis reinforcement for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy

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Summary of findings 3. Application of fibrin sealants to pancreatic duct occlusion for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy

Application of fibrin sealants to pancreatic duct occlusion for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy
Patient or population: people undergoing pancreaticoduodenectomy Setting: hospital Intervention: fibrin sealant Comparison: no fibrin sealant
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no fibrin sealants	Risk with fibrin sealants
Postoperative pancreatic fistula (ISGPF definition)	This outcome was not reported in any of the included studies.
Postoperative mortality Follow up: 30 days	Study population		Peto OR 1.41 (0.63 to 3.13)	351 (2 studies)	⊕⊕⊝⊝ low^1,2
	61 per 1000	84 per 1000 (40 to 170)
	Moderate
	61 per 1000	84 per 1000 (40 to 170)
Overall postoperative morbidity Follow up: 30 days	Study population		RR 1.16 (0.67 to 2.02)	351 (2 studies)	⊕⊝⊝⊝ very low^1,2,3,4
	276 per 1000	320 per 1000 (185 to 558)
	Moderate
	277 per 1000	321 per 1000 (185 to 559)
Reoperation rate Follow up: 30 days	Study population		RR 0.85 (0.52 to 1.41)	351 (2 studies)	⊕⊝⊝⊝ very low^1,2,3
	160 per 1000	136 per 1000 (83 to 225)
	Moderate
	160 per 1000	136 per 1000 (83 to 226)
Serious adverse events (Diabetes mellitus) Follow‐up: 3 to 12 months	3 months follow up		‐	169 (1 study)	⊕⊕⊝⊝ low^1,3,5
	108 per 1000	337 per 1000
	12 months follow up
	145 per 1000	337 per 1000
Quality of life	This outcome was not reported in any of the included studies.
Cost effectiveness	This outcome was not reported in any of the included studies.
Length of hospital stay (days)	The mean length of hospital stay was 16.5 days	The mean length of hospital stay was 0.58 days higher (5.74 lower to 6.89 higher)	MD 0.58 (‐5.74 to 6.89)	351 (2 studies)	⊕⊕⊝⊝ low^1,3,5
The basis for the assumed risk* (e.g. the 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; RR: Risk ratio; OR: Odds ratio; MD: Mean difference; ISGPF: International Study Group on Pancreatic Fistula
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.
¹ Downgraded two levels for very serious imprecision (small sample size, confidence intervals of risk ratios overlapped 0.75 and 1.25). ² Publication bias could not be assessed because of there being few studies. ³ Downgraded one level for serious risk of bias. ⁴ Downgraded one level for serious heterogeneity ⁵ Downgraded one level for serious imprecision (small sample size; total population size was less than 400).

Summary of findings 3. Application of fibrin sealants to pancreatic duct occlusion for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy

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Comparison 1. Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative pancreatic fistula (ISGPF definition) Show forest plot	4	755	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.68, 1.35]

1.1 Fibrin glue	1	109	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.44, 2.37]
1.2 Fibrin sealant patch	3	646	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.58, 1.45]
2 Postoperative mortality Show forest plot	6	804	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.52 [0.05, 5.03]

2.1 Fibrin glue	3	158	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 Fibrin sealant patch	3	646	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.52 [0.05, 5.03]
3 Overall postoperative morbidity Show forest plot	3	646	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.97, 1.58]

4 Reoperation rate Show forest plot	2	376	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.15, 1.71]

5 Length of hospital stay Show forest plot	4	755	Mean Difference (IV, Random, 95% CI)	0.32 [‐1.06, 1.70]

Comparison 1. Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy)

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Comparison 2. Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative pancreatic fistula (ISGPF definition) Show forest plot	1	57	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.01, 5.06]

1.1 Fibrin glue	1	57	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.01, 5.06]
1.2 Fibrin sealant patch	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Postoperative mortality Show forest plot	3	251	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.15 [0.00, 7.76]

2.1 Fibrin glue	3	251	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.15 [0.00, 7.76]
2.2 Fibrin sealant patch	0	0	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Overall postoperative morbidity Show forest plot	2	181	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.65, 1.45]

4 Reoperation rate Show forest plot	2	181	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.33, 2.11]

5 Length of hospital stay Show forest plot	2	181	Mean Difference (IV, Random, 95% CI)	‐1.58 [‐3.96, 0.81]

Comparison 2. Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy)

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Comparison 3. Fibrin sealants versus no fibrin sealant (pancreatic duct occlusion after pancreaticoduodenectomy)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative mortality Show forest plot	2	351	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.41 [0.63, 3.13]

1.1 Fibrin glue	2	351	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.41 [0.63, 3.13]
1.2 Fibring sealant patch	0	0	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Overall postoperative morbidity Show forest plot	2	351	Risk Ratio (M‐H, Random, 95% CI)	1.16 [0.67, 2.02]

3 Reoperation rate Show forest plot	2	351	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.52, 1.41]

4 Length of hospital stay Show forest plot	2	351	Mean Difference (IV, Random, 95% CI)	0.58 [‐5.74, 6.89]

Comparison 3. Fibrin sealants versus no fibrin sealant (pancreatic duct occlusion after pancreaticoduodenectomy)

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