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Cochrane Database of Systematic Reviews

Gastrectomía laparoscópica versus abierta para el cáncer gástrico

Información

DOI:
https://doi.org/10.1002/14651858.CD011389.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 31 marzo 2016see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Salud digestiva

Copyright:
  1. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Lawrence MJ Best

    Department of Surgery, Royal Free Campus, UCL Medical School, London, UK

  • Muntzer Mughal

    University College Hospital, London, UK

  • Kurinchi Selvan Gurusamy

    Correspondencia a: Department of Surgery, Royal Free Campus, UCL Medical School, London, UK

    [email protected]

Contributions of authors

Conceiving the review: KG.
Designing the review: KG, MM.
Co‐ordinating the review: KG.
Designing search strategies: KG.
Writing the review: LB, KG.
Providing general advice on the review: MM.
Securing funding for the review: KG.
Performing previous work that was the foundation of the current study: KG.

Sources of support

Internal sources

  • University College London, UK.

External sources

  • National Institute for Health Research, UK.

    This report is independent research, funded by the National Institute for Health Research (NIHR Cochrane Programme Grants, 13/89/03 ‐ Evidence‐based diagnosis and management of upper digestive, hepato‐biliary, and pancreatic disorders). The views expressed in this publication are those of the author(s) and not necessarily those of the National Health Service (NHS), the National Institute for Health Research, or the Department of Health.

Declarations of interest

This report is independent research, funded by the National Institute for Health Research (NIHR Cochrane Programme Grants, 13/89/03 ‐ Evidence‐based diagnosis and management of upper digestive, hepato‐biliary, and pancreatic disorders). The views expressed in this publication are those of the author(s) and not necessarily those of the National Health Service (NHS), the National Institute for Health Research, or the Department of Health.

LMJB: none known.

MM: none known.

KSG: none known.

Acknowledgements

We thank the authors of the trials who provided additional information for this review.

We thank Karin Dearness, Managing Editor, Cochrane Upper Gastrointestinal and Pancreatic Diseases (UGPD) Group for providing administrative and logistical support for the conduct of the current review, and Racquel Simpson, Trials Search Co‐ordinator, Cochrane UGPD Group for developing and executing the search strategies.

We thank the peer reviewers, copy editors and Cochrane Editorial Unit for their comments.

Version history

Published

Title

Stage

Authors

Version

2016 Mar 31

Laparoscopic versus open gastrectomy for gastric cancer

Review

Lawrence MJ Best, Muntzer Mughal, Kurinchi Selvan Gurusamy

https://doi.org/10.1002/14651858.CD011389.pub2

2014 Nov 17

Laparoscopic versus open gastrectomy for gastric cancer

Protocol

Kurinchi Selvan Gurusamy

https://doi.org/10.1002/14651858.CD011389

Differences between protocol and review

The search strategy was revised after the protocol was published as it was not sufficiently sensitive to identify known trials.

Keywords

MeSH

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.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

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

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

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

Study flow diagram.
Figuras y tablas -
Figure 3

Study flow diagram.

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 1 Short‐term mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 1 Short‐term mortality.

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 2 Long‐term mortality (maximal follow‐up).
Figuras y tablas -
Analysis 1.2

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 2 Long‐term mortality (maximal follow‐up).

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 3 Proportion with a serious adverse event (< 3 months).
Figuras y tablas -
Analysis 1.3

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 3 Proportion with a serious adverse event (< 3 months).

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 4 Short‐term recurrence.
Figuras y tablas -
Analysis 1.4

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 4 Short‐term recurrence.

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 5 Long‐term recurrence (maximal follow‐up).
Figuras y tablas -
Analysis 1.5

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 5 Long‐term recurrence (maximal follow‐up).

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 6 Proportion with an adverse event (< 3 months).
Figuras y tablas -
Analysis 1.6

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 6 Proportion with an adverse event (< 3 months).

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 7 Proportion requiring blood transfusion during or within a week of surgery.
Figuras y tablas -
Analysis 1.7

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 7 Proportion requiring blood transfusion during or within a week of surgery.

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 8 Quantity of perioperative blood transfused.
Figuras y tablas -
Analysis 1.8

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 8 Quantity of perioperative blood transfused.

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 9 Length of hospital stay.
Figuras y tablas -
Analysis 1.9

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 9 Length of hospital stay.

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 10 Proportion with positive resection margins at histopathological examination.
Figuras y tablas -
Analysis 1.10

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 10 Proportion with positive resection margins at histopathological examination.

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 11 Number of lymph nodes harvested.
Figuras y tablas -
Analysis 1.11

Comparison 1 Laparoscopic versus open gastrectomy, Outcome 11 Number of lymph nodes harvested.

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 1 Short‐term mortality (stratified by early versus advanced cancer).
Figuras y tablas -
Analysis 2.1

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 1 Short‐term mortality (stratified by early versus advanced cancer).

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 2 Long‐term mortality (maximal follow‐up) (stratified by early versus advanced cancer).
Figuras y tablas -
Analysis 2.2

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 2 Long‐term mortality (maximal follow‐up) (stratified by early versus advanced cancer).

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 3 Proportion with a serious adverse event (< 3 months) (stratified by early versus advanced cancer).
Figuras y tablas -
Analysis 2.3

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 3 Proportion with a serious adverse event (< 3 months) (stratified by early versus advanced cancer).

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 4 Short‐term mortality (stratified by type of gastrectomy).
Figuras y tablas -
Analysis 2.4

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 4 Short‐term mortality (stratified by type of gastrectomy).

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 5 Long‐term mortality (maximal follow‐up) (stratified by type of gastrectomy).
Figuras y tablas -
Analysis 2.5

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 5 Long‐term mortality (maximal follow‐up) (stratified by type of gastrectomy).

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 6 Proportion with a serious adverse event (< 3 months) (stratified by type of gastrectomy).
Figuras y tablas -
Analysis 2.6

Comparison 2 Laparoscopic versus open gastrectomy (subgroup analysis), Outcome 6 Proportion with a serious adverse event (< 3 months) (stratified by type of gastrectomy).

Summary of findings for the main comparison. Laparoscopic gastrectomy compared to open gastrectomy for gastric cancer (primary outcomes)

Laparoscopic gastrectomy compared to open gastrectomy for gastric cancer (primary outcomes)

Patient or population: patients with gastric cancer
Settings: secondary or tertiary setting
Intervention: laparoscopic gastrectomy
Comparison: open gastrectomy

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

Open gastrectomy

Laparoscopic gastrectomy

Short‐term mortality

3 per 1000

6 per 1000
(2 to 18)

RR 1.60
(0.50 to 5.10)

2335
(11 studies)

⊕⊕⊝⊝
low1

Long‐term mortality (maximal follow‐up)

448 per 1000

428 per 1000
(340 to 524)

HR 0.94
(0.70 to 1.25)

195
(3 studies)

⊕⊝⊝⊝
very low1,2

Proportion with a serious adverse event (< 3 months)

60 per 1000

36 per 1000
(16 to 81)

RR 0.60
(0.27 to 1.34)

432
(8 studies)

⊕⊝⊝⊝
very low1,2

Health‐related quality of life during short‐term (four weeks to three months) or medium‐term (more than three months to one year) was not reported.

*The basis for the assumed risk was the mean control group proportion. 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; RR: risk 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.

1 There was unclear or high risk bias within the trials (downgraded by two levels).
2 The confidence intervals were wide (overlaps no effect and clinically significantly effect) and the sample size was small (downgraded by two levels).

Figuras y tablas -
Summary of findings for the main comparison. Laparoscopic gastrectomy compared to open gastrectomy for gastric cancer (primary outcomes)
Summary of findings 2. Laparoscopic gastrectomy compared to open gastrectomy for gastric cancer (secondary outcomes)

Laparoscopic gastrectomy compared to open gastrectomy for gastric cancer (secondary outcomes)

Patient or population: patients with gastric cancer
Settings: secondary or tertiary setting
Intervention: laparoscopic gastrectomy
Comparison: open gastrectomy

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Open gastrectomy

Laparoscopic gastrectomy

Long‐term recurrence (maximal follow‐up)

450 per 1000

433 per 1000
(342 to 540)

HR 0.95
(0.70 to 1.30)

162
(4 studies)

⊕⊝⊝⊝
very low1,2

Proportion with an adverse event (< 3 months)

207 per 1000

161 per 1000
(124 to 209)

RR 0.78
(0.60 to 1.01)

2490
(11 studies)

⊕⊝⊝⊝
very low1,3

Quantity of perioperative blood transfused

The mean quantity of perioperative blood transfused in the control groups was
0.08 litres

The mean quantity of perioperative blood transfused in the intervention groups was
0.05 standard deviations higher
(0.27 lower to 0.38 higher)

143
(2 studies)

⊕⊝⊝⊝
very low1,2

SMD 0.05 (‐0.27 to 0.38)

Length of hospital stay

The mean length of hospital stay in the intervention groups was
1.82 lower
(3.72 lower to 0.07 higher)

319
(6 studies)

⊕⊝⊝⊝
very low1,2,4

Number of lymph nodes harvested

The mean number of lymph nodes harvested in the control groups was
27

The mean number of lymph nodes harvested in the intervention groups was
0.63 lower
(1.51 lower to 0.25 higher)

472
(9 studies)

⊕⊝⊝⊝
very low1,4

There were no events in either group for short‐term recurrence (103 participants (3 studies)), proportion requiring blood transfusion (66 participants (2 studies)), proportion with positive resection margin (incomplete cancer resection) (14 participants (1 study)).

None of the trials reported on measures of earlier postoperative recovery such as time to return to normal activity or time to return to work.

*The basis for the assumed risk was the mean control group proportion. 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; RR: risk ratio; SMD: standardised mean difference.

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 There was unclear or high risk of bias within the trials (downgraded by two levels). Please see Figure 1 and Figure 2 which show this.
2 The confidence intervals were wide (overlaps no effect and clinically significantly effect) and the sample size was small (downgraded by two levels).
3 Visual inspection revealed that studies with large variance were more in the favour of laparoscopic group than the open group, suggesting potential reporting bias (downgraded by one level).
4 Significant heterogeneity detected in the studies by the I2 values and Chi2 test (downgraded by two levels).

Figuras y tablas -
Summary of findings 2. Laparoscopic gastrectomy compared to open gastrectomy for gastric cancer (secondary outcomes)
Comparison 1. Laparoscopic versus open gastrectomy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Short‐term mortality Show forest plot

11

2335

Risk Ratio (M‐H, Fixed, 95% CI)

1.60 [0.50, 5.10]

2 Long‐term mortality (maximal follow‐up) Show forest plot

3

195

Hazard Ratio (Fixed, 95% CI)

0.94 [0.70, 1.25]

3 Proportion with a serious adverse event (< 3 months) Show forest plot

8

432

Risk Ratio (M‐H, Fixed, 95% CI)

0.60 [0.27, 1.34]

4 Short‐term recurrence Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

5 Long‐term recurrence (maximal follow‐up) Show forest plot

4

Hazard Ratio (Fixed, 95% CI)

Totals not selected

6 Proportion with an adverse event (< 3 months) Show forest plot

11

2490

Risk Ratio (M‐H, Random, 95% CI)

0.78 [0.60, 1.01]

7 Proportion requiring blood transfusion during or within a week of surgery Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

8 Quantity of perioperative blood transfused Show forest plot

2

143

Std. Mean Difference (IV, Fixed, 95% CI)

0.05 [‐0.27, 0.38]

9 Length of hospital stay Show forest plot

8

444

Mean Difference (IV, Random, 95% CI)

‐1.38 [‐2.57, ‐0.19]

10 Proportion with positive resection margins at histopathological examination Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

11 Number of lymph nodes harvested Show forest plot

9

472

Mean Difference (IV, Fixed, 95% CI)

‐0.63 [‐1.51, 0.25]

Figuras y tablas -
Comparison 1. Laparoscopic versus open gastrectomy
Comparison 2. Laparoscopic versus open gastrectomy (subgroup analysis)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Short‐term mortality (stratified by early versus advanced cancer) Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 Early gastric cancer

5

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Advanced gastric cancer

2

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Long‐term mortality (maximal follow‐up) (stratified by early versus advanced cancer) Show forest plot

2

Hazard Ratio (Fixed, 95% CI)

Totals not selected

2.1 Early gastric cancer

1

Hazard Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Advanced gastric cancer

1

Hazard Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Proportion with a serious adverse event (< 3 months) (stratified by early versus advanced cancer) Show forest plot

5

262

Risk Ratio (M‐H, Fixed, 95% CI)

0.58 [0.21, 1.60]

3.1 Early gastric cancer

4

166

Risk Ratio (M‐H, Fixed, 95% CI)

0.44 [0.14, 1.39]

3.2 Advanced gastric cancer

1

96

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [0.12, 68.98]

4 Short‐term mortality (stratified by type of gastrectomy) Show forest plot

10

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 Subtotal gastrectomy

10

2239

Risk Ratio (M‐H, Fixed, 95% CI)

1.60 [0.50, 5.10]

5 Long‐term mortality (maximal follow‐up) (stratified by type of gastrectomy) Show forest plot

2

Hazard Ratio (Fixed, 95% CI)

Totals not selected

5.1 Subtotal gastrectomy

2

Hazard Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Proportion with a serious adverse event (< 3 months) (stratified by type of gastrectomy) Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

6.1 Subtotal gastrectomy

7

336

Risk Ratio (M‐H, Fixed, 95% CI)

0.52 [0.22, 1.22]

Figuras y tablas -
Comparison 2. Laparoscopic versus open gastrectomy (subgroup analysis)