Prophylactic abdominal drainage versus no-drainage after left pancreatectomy: a systematic review and meta-analysis
Highlight box
Key findings
• There was no difference in major morbidity between the drainage group and the no-drainage group after left pancreatectomy.
• The rate of postoperative pancreatic fistula with grade B or C was lower in the no-drainage group.
What is known and what is new?
• Routine drainage following left pancreatectomy is a common practice in many medical centers, but its efficacy is a subject of controversy.
• Postoperative outcomes after left pancreatectomy without drainage were superior to or equivalent to those with drainage.
What is the implication, and what should change now?
• Considering the comparable safety in major morbidity and the benefits of having a lower rate of postoperative pancreatic fistula with grade B or C, the no-drainage policy should be implemented routinely after left pancreatectomy.
• Further randomized controlled trials are required to confirm these findings in the future.
Introduction
Patients undergo left pancreatectomy (LP) for the treatment of benign and malignant tumors and precancerous lesions in the body or at tail of the pancreas, with or without splenectomy (1,2). The incidence of major morbidity is 20% to 40% (2,3). The Grade B and C postoperative pancreatic fistula (POPF B/C) is considered a significant complication, as it is associated with bleeding, infection, and even death after pancreatic surgery (4,5). The POPF occurs due to postoperative wound formation in the pancreas and the potential risk of leakage of pancreatic fluid which is rich in pancreatic enzymes (6). Theoretically, leaking pancreatic fluid can be drained by prophylactic placement of a drain, thereby reducing the extent and incidence of associated complications. Additionally, the abdominal drainage fluid allows for early monitoring of the occurrence of pancreatic fistula, bleeding, and other complications, facilitating perioperative management and treatment (7).
However, abdominal drainage also brings potential infections and other complications (8). Thus, the timing of tube removal remains a contentious issue in research (9). Moreover, there are also proposals of having no drain be placed. However, the accumulated pancreatic fluid may lead to the development of more severe POPF (10). A meta-analysis that included one randomized controlled trial (RCT) and four observational clinical studies (OCS) indicated a reduction in major morbidity and POPF following LP without drainage compared to those with drainage (11). However, the study included only one RCT, which did not support the conclusion (12). A recent international multicenter RCT conducted by van Bodegraven et al. revealed no disparity in major morbidity, while POPF rate was lower in the no-drainage group (13). Furthermore, the three recent high-quality OCS arrived at the same conclusion (14-16). Consequently, a new meta-analysis is imperative to confirm the viability of a no-drain policy and to furnish evidence for altering clinical practice. We present this article in accordance with the PRISMA reporting checklist (available at https://gs.amegroups.com/article/view/10.21037/gs-24-351/rc) (17).
Methods
Protocol and registration
This systematic review adheres to the recommendations of the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) guidelines (18). The protocol for this systematic review and meta-analysis has been registered in PROSPERO (ID: CRD42024571558).
Literature search
An extensive literature search was conducted in PubMed, MEDLINE, Embase, Web of Science, and the Cochrane Library from inception to June 2024. Keywords and MeSH (Medical Subject Headings) terms were combined for the search, including ‘left pancreatectomy’, ‘distal pancreatectomy’, ‘drain’, ‘drainage’, ‘no-drain’, and ‘no drainage’. Two authors independently searched the literature, deleted duplicates, and screened studies based on titles and abstracts. The selected articles were reviewed by both authors, and the references of these articles were further searched manually. When disagreements arose, they were resolved by consultation with the instructor until consensus was reached.
Inclusion and exclusion criteria
The inclusion criteria were as follows: (I) patients underwent LP; (II) compared abdominal drain with no drain; (III) at least one outcome could be merged. The exclusion criteria were as follows: (I) abstracts, letters, editorials, expert opinions, case reports, and reviews without original data; (II) studies containing data on other surgical procedures; (III) studies containing the same patient data.
Outcomes of interest and definitions
The primary outcome was major morbidity, defined as complications greater than or equal to grade 3 according to the Clavien-Dindo classification (19). The secondary outcomes included POPF B/C, interventional drainage, reoperation, readmission, hospital stay, and 90-day mortality. The POPF B/C was defined according to the International Study Group of Pancreatic Surgery (ISGPS) (20). Interventional drainage was defined as radiation-guided percutaneous drainage or endoscopic catheter drainage after LP.
Data extraction
Data were extracted independently by the two authors and cross-checked to ensure consistency. Extracted data included baseline characteristics such as first author, year of publication, country, study type, sample size, age, sex, body mass index (BMI), American Society of Anesthesiology score, surgical procedure (open or minimally invasive), pancreatic texture, pancreatic duct diameter, splenectomy, vascular resection, operative time (minutes), estimated blood loss, intraoperative transfusion, and the outcomes mentioned above.
Study quality
The Modified Jadad Scale was used to evaluate RCTs, including random sequence generation, allocation concealment, blinding, and withdrawals, with a total score of seven (21). For OCS, the modified Newcastle-Ottawa Scale was used for evaluation (22). Two authors independently assessed the quality of the included studies, resolving disagreements through discussion. Publication bias was assessed using funnel plots.
Statistical analysis
Data analysis was conducted using Review Manager 5.4 software (The Cochrane Collaboration, Oxford, UK). Odds ratios (ORs) were used to measure differences in binary data, and mean differences (MDs) for continuous data. A 95% confidence interval (CI) was used for all effect sizes. Fixed-effects or random-effects models were chosen based on heterogeneity, assessed using I2. If I2 was less than 50%, a fixed-effects model was used; otherwise, a random-effects model was employed. A P-value of less than 0.05 was considered statistically significant. Egger’s test was used to assess publication bias, with significance set at P<0.05. When mean and standard deviation were missing, data were converted according to the recommendations of the Cochrane Handbook or Hozo et al. (23,24).
We analyzed the RCT and OCS data separately, with primary focus on RCT data for discussion. Sensitivity analysis was performed on OCS by systematically removing each included study to determine the stability of the results.
Results
Study selection and characteristics
A total of 3,220 records were retrieved, and 1,324 duplicates were removed. After reviewing the title and abstract, 18 articles were selected. Following a full-text assessment, eight articles were excluded for the following reasons: one was a sing-arm study; data from three articles could not be separated (25-27); two were proposals (28,29), and two were conference abstracts (30,31). Ultimately, 10 studies were included, comprising two RCTs (12,13) and eight observational studies (14-16,32-36), involving a total of 3,505 patients. The maximum sample size was 1,158, and the minimum sample size was 58. The PRISMA flow diagram for the systematic review is shown in Figure 1. The basic characteristics of the included studies are shown in Table 1. The outcomes of interest are shown in Table S1, the meta-analysis for aggregated data is shown in Figure 2, and the results of the meta-analysis are shown in Table 2. The qualitative evaluation of the studies is shown in Table S2.
Table 1
Characteristics | Paulus (32) | Correa-Gallego (33) | Behrman (34) | Van Buren (12) | Mangieri (35) | van Bodegraven (15) | Nickel (14) | van Bodegraven (13) | Magnin (36) | Mazzola (16) |
---|---|---|---|---|---|---|---|---|---|---|
Year | 2012 | 2013 | 2015 | 2017 | 2020 | 2022 | 2022 | 2024 | 2024 | 2024 |
Country | USA | USA | USA | USA | USA | USA | Germany | Netherlands | USA | Italy |
Type of study | OCS | OCS | OCS | RCT | OCS | OCS | OCS | RCT | OCS | OCS |
Sample | ||||||||||
No drainage | 30 | 196 | 116 | 170 | 173 | 74 | 56 | 138 | 585 | 29 |
Drainage | 39 | 154 | 116 | 174 | 985 | 74 | 56 | 144 | 167 | 29 |
Sex (female/male) | ||||||||||
No drainage | – | – | 67/49 | 73/67 | 108/65 | 46/28 | 28/28 | 75/63 | 326/259 | 16/13 |
Drainage | – | – | 61/61 | 72/72 | 571/414 | 47/27 | 29/27 | 73/71 | 2/95 | 13/16 |
Age | ||||||||||
No drainage | 58 (52–68) | – | 59 | 60 (47–73) | 58 (49–70) | 60.3±14.6 | 64.1±10.8 | 62.9±12.5 | 64 (54, 72) | 71 (64–76) |
Drainage | 52 (44–66) | – | 57 | 61 (49–73) | 62 (52–70) | 59.4±15.8 | 64.1±12.6 | 61.9±15.5 | 66 (55, 73) | 62 (52–79) |
BMI, kg/m2 | ||||||||||
No drainage | – | – | – | 27.7 (23.6–32.6) | – | 26±4 | 25.2±5.0 | 26.6±4.5 | 27.1 (23.9–30.5) | 24.8 (21.5–26.5) |
Drainage | – | – | – | 28.6 (25.2–33.4) | – | 26±5 | 25.0±4.2 | 26.3±4.4 | 28.0 (25.3–33.2) | 24.3 (21.6–27.1) |
ASA (<III, ≥III) | ||||||||||
No drainage | – | – | 41, 75 | 50, 120 | 55, 118 | 45, 29 | 36, 20 | 42, 96 | 241, 343 | 18, 11 |
Drainage | – | – | 43, 82 | 55, 121 | 331, 654 | 38, 36 | 34, 21 | 34, 110 | 41, 125 | 20, 9 |
Surgical procedure (open/minimally invasive) | ||||||||||
No drainage | – | – | 32/84 | 75/75 | 78/95 | 8/66 | – | 38/100 | 438/147 | 0/29 |
Drainage | – | – | 32/84 | 77/77 | 454/531 | 12/62 | – | 38/104 | 114/17 | 0/29 |
Texture (hard/intermediate/soft) | ||||||||||
No drainage | –/–/28 | – | 26/15/75 | –/–/135 | – | – | – | – | 74/–/507 | – |
Drainage | –/–/31 | – | 36/13/67 | –/–/138 | – | – | – | – | 47/–/118 | – |
Pancreatic duct diameter, mm | ||||||||||
No drainage | 2 (1–3) | – | – | – | 2 (2–2) | – | – | 1 (1–3) | – | – |
Drainage | 2 (1–8) | – | – | – | 2 (2–2) | – | – | 1 (1–2) | – | – |
Splenectomy | ||||||||||
No drainage | – | 144 | – | 155 | – | 66 | – | 87 | 572 | 13 |
Drainage | – | 123 | – | 157 | – | 47 | – | 93 | 162 | 10 |
Operative time, min | ||||||||||
No drainage | 195 (176–260) | 152 (118–188) | 228 | 203 (139–261) | 212 (167–258) | 182 (159–213) | 191±67.1 | 194 (168–251) | 142 (110–180) | 270 (225–295) |
Drainage | 249 (196–290) | 191 (154–229) | 222 | 196 (148–260) | 206 (160–275) | 180 (170–205) | 189.3±73.4 | 215 (180–269) | 186 (150–239) | 260 (213–310) |
Estimated blood loss, mL | ||||||||||
No drainage | 200 (100–300) | 200 (100–400) | – | 150 (75–400) | – | 50 (50–100) | 563.6±725.6 | 100 (50–250) | 150 (50–250) | 100 (50–350) |
Drainage | 450 (300–750) | 400 (200–800) | – | 200 (100–400) | – | 100 (100–150) | 713.4±716.3 | 100 (50–300) | 250 (100–500) | 180 (95–275) |
Data are presented as n, n/N, mean ± standard deviation, or median (interquartile range), unless otherwise specified. OCS, observational clinical studies; RCT, randomized controlled trial; BMI, body mass index; ASA, American Society of Anesthesiology score.
Table 2
Outcomes | Type | Studies | Total | Relative effect (95% CI) | P value | I2 (%) |
---|---|---|---|---|---|---|
Major morbidity | RCTs | 2 | 626 | OR 0.79 (0.54, 1.15) | 0.22 | 0 |
OCS | 7 | 2,127 | OR 0.65 (0.49, 0.85) | 0.002 | 24 | |
Fistula B/C | RCTs | 2 | 626 | OR 0.47 (0.30, 0.73) | <0.001 | 35 |
OCS | 7 | 2,879 | OR 0.42 (0.33, 0.54) | <0.001 | 24 | |
Interventionaldrainage | RCTs | 2 | 626 | OR 0.74 (0.45, 1.21) | 0.22 | 10 |
OCS | 7 | 2,821 | OR 0.63 (0.48, 0.82) | <0.001 | 27 | |
Reoperation | RCTs | 2 | 626 | OR 0.95 (0.43, 2.11) | 0.90 | 3 |
OCS | 8 | 2,879 | OR 0.57 (0.34, 0.95) | 0.03 | 0 | |
Hospital stay, days | RCTs | 2 | 626 | MD −0.62 (−1.11, −0.14) | 0.01 | 56 |
OCS | 6 | 1,895 | MD −2.78 (−4.07, −1.49) | <0.001 | 94 | |
Readmission | RCTs | 2 | 626 | OR 0.88 (0.60, 1.31) | 0.54 | 0 |
OCS | 6 | 2,578 | OR 0.64 (0.49, 0.82) | <0.001 | 0 | |
Mortality | RCTs | 2 | 626 | OR 5.24 (0.61, 45.07) | 0.13 | 0 |
OCS | 3 | 958 | OR 1.19 (0.28, 5.00) | 0.81 | 0 |
CI, confidence interval; RCT, randomized controlled trial; OR, odds ratio; OCS, observational clinical studies; MD, mean difference.
Results of the meta-analysis
The meta-analysis for aggregated data is shown in Figure 2.
Primary outcomes
Major morbidity was reported in nine studies (12-16,32-35). The rate of major morbidity in RCTs was 21.1% (65/308) in the no-drainage group and 25.2% (80/318) in the drainage group. There was no difference in major morbidity in RCTs between the two groups (OR =0.79; 95% CI: 0.54–1.15; P=0.22). However, the meta-analysis showed significant differences in major morbidity between the two groups in OCS (OR =0.65; 95% CI: 0.49–0.85; P=0.002).
Secondary outcomes
All 10 studies reported POPF B/C (12-16,32-36). In the RCTs, the POPF B/C rate was 11.7% (36/308) in the no-drainage group and 22% (70/318) in the drainage group. The POPF rate was lower in the no-drainage group than in the drainage group, in both RCTs (OR =0.47; 95% CI: 0.30–0.73; P<0.001) and OCS (OR =0.42; 95% CI: 0.33–0.54; P<0.001). Interventional drainage was reported in nine studies (12-15,32-36). There was no difference in the two groups in RCTs (OR =0.74; 95% CI: 0.45–1.21; P=0.22). In OCS, the rate of interventional drainage was lower in the no-drainage group than in the drainage group (OR =0.63; 95% CI: 0.48–0.82; P<0.001). All 10 studies reported reoperation (12-16,32-36). There was no difference in reoperation in RCTs between the two groups (OR =0.95; 95% CI: 0.43–2.11; P=0.90). However, the meta-analysis showed significant differences in major morbidity between the two groups in OCS (OR =0.57; 95% CI: 0.34–0.95; P=0.03). Eight studies reported data on length of hospital stay that could be combined (12-16,32,33,35). In both the RCTs and OCS, the meta-analysis showed a shorter length of hospital stay in the no-drainage group compared to the drainage group (RCTs: MD =−0.62; 95% CI: −1.11 to −0.14; P=0.01). Readmission was reported in eight studies (12-16,33,35,36). In RCTs, there was no difference between the two groups (OR =0.88; 95% CI: 0.60–1.31; P=0.54). However, the readmission rate of OCS was lower in the no-drainage group than in the drainage group (OR =0.64; 95% CI: 0.49–0.82; P<0.001). Five studies reported the 90-day mortality (12,13,15,16,36). Pooled analysis showed no difference between the two groups in RCTs (OR =5.24; 95% CI: 0.61–45.07; P=0.13) and OCS (OR =1.19; 95% CI: 0.28–5.00; P=0.81).
Sensitivity analysis and publication bias
Sensitivity analyses were performed as planned to validate the stability of the results. The results of interventional drainage changed due to removal of the study by Magnin et al. (36). After removing one of the four studies (14,16,34,36), the results regarding reoperation changed. In all other cases, the results were stable. The funnel plot for major morbidity is shown in Figure 3. There was no evidence of publication bias in major morbidity.
Discussion
Routine drainage placement after LP is considered common practice. It was previously believed to enhance the safety of pancreatic surgery by removing fluid that accumulates in the abdominal cavity after surgery (37). However, this approach is now under increasing scrutiny, supported by emerging research suggesting comparable or even improved outcomes without drainage (13,14).
In this meta-analysis, no differences were observed in major morbidity, interventional drainage, reoperation, readmission, or mortality rates between the drainage and no-drainage groups. However, POPF rates and hospital stays were more favorable in the no-drainage group compared to the drainage group. The previous meta-analysis has shown lower incidences of major morbidity and POPF in the no-drainage group compared to the drainage group (11). Therefore, the authors recommend that routine abdominal drainage should be reconsidered after LP. However, this recommendation has not significantly altered clinical practices, as many centers continue to perform routine drainage. According to the 2023 Brescia guidelines, the decision to use drainage following LP remains at the discretion of the surgeon, without a strong recommendation (38). Subsequently, a RCT was published, and its results were consistent with our conclusions (13).
Several reasons explain why our results differed from the previous meta-analysis regarding major complications (11). First, RCTs were analyzed separately, and both RCTs reached conclusions similar to ours. The results of the RCTs were prioritized due to their higher quality and grade of evidence compared to the OCS. However, the number of RCTs was limited, and the total sample size was smaller. Second, the results regarding major morbidity differed only in the study by Correa-Gallego et al. (33). This discrepancy may be attributed to variations in surgical techniques across different centers and perioperative advancements in recent years, which have contributed to a decrease in the incidence of major morbidity (6).
As we know, the POPF is a serious complication after LP. Surgeons have long believed that drainage could reduce the incidence of POPF. However, recent evidence suggests that drainage may actually increase the incidence of POPF (13,14). In LP, after dissecting the pancreas, the wound is sutured and left sterile, unlike in pancreaticoduodenectomy (8). The implantation of a drainage tube can elevate the risk of infection by foreign pathogens (39). Furthermore, the mechanical irritation caused by the drain may inflame the pancreatic stump, leading to delayed wound healing (40). Additionally, creating pancreatic drainage outflow channels may contribute to pancreatic juice reabsorption and packaging, thus hindering the natural sealing of the pancreas (41). These factors likely contribute to the development of POPF. The most recent RCT stratified the risk of pancreatic fistula to identify a population suitable for drainage, but no advantage of drainage was found (13). Several factors can influence the occurrence of POPF after LP, such as the texture of the pancreas, the diameter of the main pancreatic duct, intraoperative blood loss, BMI, and the skill level of the operating surgeon (42,43). The estimated blood loss in the no-drainage group was significantly less than that in the drainage group in three studies (32,33,36), which introduced a significant selection bias to the results of the POPF analysis in OCS. Undoubtedly, drainage placement aids in facilitating the early detection of POPF and assisting in optimal perioperative management (7,44). However, the challenge lies in identifying the appropriate candidates for drainage.
Although the results regarding the length of hospital stay varied, the median length of hospital stay was consistent across RCTs, making clinical relevance difficult to analyze (12,13). This finding is clinically significant in OCS; however, physicians may have chosen to adopt drainage on patients with poorer conditions, contributing to longer hospital stays for those who received drainage. In OCS, the reoperation rate in the no-drainage group was lower than that in the drainage group, which may be attributed to the reduced rates of POPF B/C in the drainage group. The absence of differences in interventional drainage, readmission, and mortality rates in the no-drainage group reaffirms that no drainage is equally safe and reliable. In sensitivity analyses, the majority of the changes in results were due to the removal of studies published in recent years. This suggests that the results may be related to advances in surgical techniques and perioperative management (45,46). Additionally, centers with varying capacities could contribute to heterogeneity in the results (47).
There are still some limitations in this study. First, only two RCTs were included, reducing the stability and reliability of our results. Second, only one article risk-stratified POPF, making it challenging to conduct subgroup analyses based on risk stratification and risk factors. Third, no studies investigated on postoperative long-term outcomes such as pseudocyst formation.
Conclusions
Considering the comparable safety in major morbidity and the benefits of having a lower rate of POPF B/C, we recommend a no-drainage policy in LP. However, further studies are necessary to confirm this recommendation. Moreover, it is crucial to identify patients who would benefit from drainage.
Acknowledgments
Funding: This study was supported by
Footnote
Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://gs.amegroups.com/article/view/10.21037/gs-24-351/rc
Peer Review File: Available at https://gs.amegroups.com/article/view/10.21037/gs-24-351/prf
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-24-351/coif). The authors have no conflicts of interest to declare.
Ethical Statement:
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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