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ORIGINAL ARTICLE
Year : 2018  |  Volume : 14  |  Issue : 10  |  Page : 724-729

Safety and feasibility of enhanced recovery after surgery in the patients underwent distal pancreatectomy for pancreatic cancer


1 Department of Gastrointestinal Surgery, Kanagawa Cancer Center; Department of Surgery, Yokohama City University, Yokohama, Kanagawa, Japan
2 Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
3 Department of Hepatobiliary Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
4 Department of Anesthesiology, Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
5 Department of Surgery, Yokohama City University, Yokohama, Kanagawa, Japan

Date of Web Publication24-Sep-2018

Correspondence Address:
Toru Aoyama
Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama 241-8515, Kanagawa Prefecture
Japan
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0973-1482.183186

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 > Abstract 


Purpose: This study assessed whether our enhanced recovery after surgery (ERAS) program for distal pancreatectomy (DP) is safe and feasible.
Patients and Methods: The subjects were patients who underwent consecutive DP between 2012 and 2014 at the Department of Gastrointestinal Surgery, Kanagawa Cancer Center. They received perioperative care according to ERAS program. All data were retrieved retrospectively. Outcome measures included postoperative mortality, morbidity, hospitalization, and 30-day readmission rate. Our ERAS program included 12 elements (4 preoperative elements, 3 intraoperative elements, and 5 postoperative elements).
Results: A total of 44 patients were studied. The overall incidence of morbidity was 29.5%, the incidence of mortality was 0%, and the incidence of readmission was 0%. Four preoperative elements and 3 intraoperative elements seemed feasible. Among the 5 postoperative elements, 4 elements seemed feasible, accounting 90%< performance rate however the early removal of catheters and drain seemed not feasible. The median postoperative hospital stay was 14 days (range: 8–39 days). The median postoperative hospital stay was 13 days (range: 8–27 days) in patients without postoperative complications while the median postoperative hospital stay was 26 days (range: 14–39 days) in patients with postoperative complications.
Conclusion: This study results suggested that our ERAS program is safe and feasible in patients who undergo DP. However, achieving compliance on the postoperative element, especially the removal of catcher and drain, was more challenging.

Keywords: Distal pancreatectomy, enhanced recovery after surgery, pancreatic cancer


How to cite this article:
Aoyama T, Kazama K, Murakawa M, Atsumi Y, Shiozawa M, Ueno M, Morimoto M, Taniguchi H, Masuda M, Morinaga S. Safety and feasibility of enhanced recovery after surgery in the patients underwent distal pancreatectomy for pancreatic cancer. J Can Res Ther 2018;14, Suppl S3:724-9

How to cite this URL:
Aoyama T, Kazama K, Murakawa M, Atsumi Y, Shiozawa M, Ueno M, Morimoto M, Taniguchi H, Masuda M, Morinaga S. Safety and feasibility of enhanced recovery after surgery in the patients underwent distal pancreatectomy for pancreatic cancer. J Can Res Ther [serial online] 2018 [cited 2019 Sep 18];14:724-9. Available from: http://www.cancerjournal.net/text.asp?2018/14/10/724/183186




 > Introduction Top


Distal pancreatectomy (DP) remains the main-stay of surgical treatment for pancreatic malignancy and offers the only chance of long-term survival. However, the morbidity after DP has been reported to range from 18% to 58%, and the complications are sometimes fatal.[1],[2],[3] More, previous studies have demonstrated that the development of postoperative complications increased the risk of disease recurrence and affected for overall survival.[4] Therefore, it is important to determine the most appropriate perioperative care.

Enhanced recovery after surgery (ERAS), fast-track, or clinical pathway programs are multimodal strategies that aim to attenuate the loss of, improve the restoration of, functional capacity after surgery.[5],[6] ERAS programs have many elements, including preoperative education, preoperative carbohydrate loading, the omission of bowel preparation, epidural analgesia without opioids, early postoperative enteral feeding, and early mobilization of patients.[7] ERAS was considered to reduce rates of morbidity, shorten the length of hospital stay.[6],[7],[8]

Recently, an international working group within the ERAS society published a comprehensive and evidence-based framework to enhance perioperative care in patients undergoing pancreaticoduodenectomy (PD). In PD surgery, several studies have reported that ERAS program is feasible and useful.[9],[10],[11],[12] However, few studies have assessed the implementation of an ERAS program following DP.[13],[14] Some studies have reported the effect on reducing postoperative length of hospital stay and hospital costs. Other studies have demonstrated low morbidity, mortality, and readmission rates following the implementation of fast-track programs. However, the safety and feasibility of ERAS have not been well evaluated in patients undergoing DP.

The aim of this study was to evaluate the safety and feasibility of implementing an ERAS program for patients undergoing DP in a high volume.


 > Patients and Methods Top


Patients and surgical procedure

The patients were selected from the medical records of consecutive 44 patients who underwent DP at Kanagawa Cancer Centre from March 2012 to October 2014. All operations were performed by four surgeons of the pancreatic unit. All pancreatic surgeries were performed in accordance with standardized procedures described the previous report.[15] Briefly, in cases of DP, we performed the radical antegrade modular pancreatosplenectomy (RAMPS) procedure in patients with adenocarcinoma of the pancreatic body and tail. The initial dissection in the RAMPS procedure begins medially. The splenic artery and vein are ligated, and the neck of the pancreas is transected. The dissection continues posterior to the aorta at the celiac and superior mesenteric trunks. The resection plane is decided based on the progression of cancer. In patients in whom the tumor appears to penetrate the adrenal gland (or more deeply), the plane of dissection is deepened to the posterior plane behind the adrenal gland.

Enhanced recovery after surgery program

In their Cochrane review, Spanjersberg et al. regard ERAS protocols as programs that include 7 or more of 17 ERAS items.[16] Our ERAS program included 12 items [Table 1]. Parameter 1 (preoperative counseling), Parameter 2 (use of oral bowel preparation), Parameter 3 (preoperative fasting and preoperative treatment with carbohydrates), Parameter 4 (no preanesthetic medication), Parameter 5 (use of epidural analgesia), Parameter 6 (use of short-acting anesthetic agent), Parameter 7 (use of warm air body heating in theater), Parameter 8 (mobilization care pathway), Parameter 9 (prevent of nausea and vomiting), Parameter 10 (stimulation of gut motility), Parameter 11 (early removal of catheters, removal of nasogastric tube (NGT) at day 1, removal of epidural and urinary catheter at day 3, and removal drain at day 7), and Parameter 12 (perioperative oral nutrition; start solid food at day 4). In this study, we set the cut off values of Parameter 11 and 12 as follows: We removed the NGT at day 1 since the un-need of NGTs in DP,[13] and abundant high-level evidence of early removal in abdominal surgery have been reported.[17] The epidural analgesia catheter was removed at day 3 since its usefulness is limited to <72 h after open abdominal surgery.[18] A urinary catheter was scheduled to be removed at day 3[19],[20] that followed the epidural analgesia removal. Our management that removes abdominal drain at day 7 seems late in compare to the recent trend of early removal.[13],[14] Oral intake of solid food at day 4 was employed since this is the standard in previous ERAS program for major upper gastrointestinal and hepatobiliary-pancreatic surgery, including PD.[9],[10],[11]
Table 1: Time table of the enhanced recovery after surgery program

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Preoperative care

Preoperative counseling was held in the outpatient clinic before hospitalization and in the ward after admission. Patients could eat a normal diet until dinner of the day before surgery. Magnesium oxide was administered on the day before surgery.

Perioperative care

The patients excluding those who had gastric obstruction with decreased output were allowed to eat until midnight on the day before the surgery and were required to drink the contents of two 500-ml plastic bottles containing oral rehydration solution until 3 h before the surgery. Anesthesia consisted of a combination of epidural analgesia and general anesthesia. To prevent hypothermia, a blanket warming system and warming set for intravenous infusions were used.

Postoperative

Day of surgery: A continuous thoracic epidural infusion of analgesics was given for 3 days after surgery. Postoperative day (POD) 1: NGT removed if drainage volume was <500 ml. Patients were encouraged to sit out of bed. POD 2: Oral intake was started with water. The patients were encouraged to walk the length of the ward. POD 3: Removal of epidural analgesia and urinary catheter was performed. POD 4: The patients started to eat soft food and were stepped up to regular food every 2 days (3 steps). Intra-abdominal drain monitored daily drain output volumes. Assessment of amylase content was performed at POD 1, POD 3, POD 5, and POD 7. Intra-abdominal drains removed if (1) drain volume was <100 ml per day (2), fluid was clear in color, and (3) amylase was <500 IU/l. The criteria for discharge were as follows: Adequate pain relief, soft diet intake, and return to preoperative mobility level, and normal laboratory data.

Definition of surgical complications

Complications of Grade 2–5 according to the Clavien-Dindo classification that occurred during hospitalization and/or within 30 days after surgery were retrospectively determined from the patient's record.[21] Pancreatic fistula was defined according to the international study group on pancreatic fistula criteria.[22] Delayed gastric emptying as indicated by an NGT that remained in situ or was reinserted after POD 3 (International Study Group of Pancreatic Surgery definition).[23] Grade 1 complications were not evaluated to exclude the possibility of a description bias in the patient's records.

Data collection and evaluations

The ERAS program evaluated in this study was developed by a team of surgeons and anesthesiologists working in close cooperation with a data safety monitoring committee. This study, a retrospective analysis, has been performed on the approval of the institutional review board of Kanagawa Cancer Center. Informed consent and using the clinical date without identifying personal information were taken before surgery. Continuous data are expressed as medians (range). This study, a retrospective analysis, has been performed on the approval of the Institutional Review Board of Kanagawa Cancer Center (Study number: 2015 KCCH epidemiologic study-32-3). Informed consent for using the clinical date without identifying personal information was taken before surgery. This study was in compliance with the declaration of Helsinki.


 > Results Top


Patients

Forty-four patients were eligible for this study and underwent DP following the introduction of an ERAS protocol. Patient's background and operative data are shown in [Table 2]. There were 21 men and 23 women. The median age was 66.5 (range: 29–86) years. The American society of Anesthesiologists physical status was 2 in most patients. Median body mass index was 22.1 (range: 16.4–31.2).
Table 2: Clinicopathological features of 44 patients

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Surgical morbidity and mortality

Postoperative complications were found in 13 of the 44 patients (29.5%). Surgical mortality was not observed. The details of the complications are shown in [Table 3]. Pancreatic fistula was the most frequently diagnosed complication, followed by abdominal abscess. Grade 2 complications occurred in 70.6% of the patients, Grade 3a in 11.8%, and Grade 3b in 17.6%.
Table 3: Details of postoperative complications

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Implementation of the enhanced recovery after surgery protocol

Implementation of the ERAS protocol was as follows: Parameter 1 (preoperative counseling): 44/44 = 100%, Parameter 2 (use of oral bowel preparation): 44/44 = 100%, Parameter 3 (preoperative fasting and preoperative treatment with carbohydrates): 44/44 = 100%, Parameter 4 (no preanesthetic medication): 44/44 = 100%, and Parameter 5 (use of epidural analgesia): 37/38 = 97.4% (38 patients (86.4%) were commenced on epidural analgesia. In 7 (13.6%) patients, an epidural catheter was not placed due to a coagulation disorder (n = 1), spinal-related disease (n = 5), or technical problem (n = 1)), Parameter 6 (use of short-acting anesthetic agent): 44/44 = 100%, Parameter 7 (use of warm air body heating in theater): 44/44 = 100%, Parameter 8 (mobilization care pathway): 42/44 = 95.5%, Parameter 9 (prevent of nausea and vomiting): 44/44 = 100%, Parameter 10 (stimulation of gut motility): 43/44 = 97.7%, Parameter 11 (early removal of catheters); (1): Removal of NGT at day 1: 44/44 = 100%, (2): Removal of epidural catheter at day 3: 27/87 = 31.0%, (3): Removal of urinary catheter at day 3: 13/37 = 35.1%, and (4): Removal drain at day 7: 10/44 = 22.7%, and Parameter 12 (Perioperative oral nutrition; start solid food at day 4): 40/44 = 90.9%. In this study, preoperative elements (Parameters 1–4) and intraoperative elements (Parameters 5–7) seemed feasible. Among the 5 postoperative elements (Parameters 8–12), Parameter 8–10 and 12, and NG-tube removal seems feasible, accounting 90%< performance rate; however, the rests of early removal of catheters seemed not feasible.

Postoperative course

The median postoperative hospital stay was 14 days (range: 8–39 days). Moreover, in patients without postoperative complications, the median postoperative hospital stay was 13 days (range: 8–27 days). On the other hands, in patients with postoperative complications, the median postoperative hospital stay was 26 days (range: 14–39 days). There were no patients were readmitted within 30 days after surgery.


 > Discussion Top


This study evaluated the safety and feasibility of the ERAS program in the patients underwent DP. In our study, the overall incidence of morbidity was 29.5%, the incidence of mortality was 0%, and the incidence of readmission was 0%. These results obtained with our ERAS program are safe compared with morbidity rates and mortality rates without ERAS program (18–58% and 0–2%). Moreover, among the 12 ERAS program elements, 4 preoperative elements, 3 intraoperative elements, and 4 postoperative elements accounted > 90% of performance rate. Therefore, our ERAS program for DP might be feasible.

In this study, the postoperative complications were found in 13 of the 44 patients (29.5%), and surgical mortality was not observed (0%). Moreover, pancreatic fistula was the most frequently diagnosed complications, followed by abdominal abscess. The overall incidence of postoperative complications and mortality was similar to in other DP fast-track studies. For example, Richardson et al. evaluated the safety and feasibility of implementing an enhanced recovery program (ERP) for 66 consecutive patients who underwent laparoscopic DP.[14] In this study, 22 patients were enrolled for the ERP and compared with previous consecutive 44 patients managed traditionally. They found that the postoperative complications rate was 6 patients (27%) in ERP while the postoperative complications rate was 17 patients (39%) in traditional management. There was no hospital death in both ERP and traditional management. In addition, Kennedy et al. evaluated the safety and feasibility of implementing a critical pathway for 111 consecutive patients who underwent both open and laparoscopic DP.[13] They found the overall postoperative complications rate was 15.7%, and the mortality rate was 1.1%. They also found that the most common complications were pancreatic fistula and wound infection. These results suggested that ERAS program is safe and feasible without an increase in postoperative complications and mortality, and the application of the ERAS program was not associated with any harmful effect.

ERAS is a structured, multimodal, perioperative strategy aiming to reduce surgical stress and to improve the patient functional capacity and quality of life after surgery.[24] It provides the patient with preoperative education regarding their expectations in recovery, and it is also intended to give a structured timeline for healthcare personnel in the management of patients. Among 12 ERAS elements, 11 ERAS elements were feasible in this study. However, postoperative element, especially early removal of catheters and drain, was more challenging. The number of patients having their urinary catheter on POD 3 was lower than expected. This was mainly due to the fact that the epidural catheter was removed on POD 4 in the majority of patients. Urinary catheters were often removed only after epidural analgesia was stopped. Why was the epidural catheter removed on POD 4? One possibility is that nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen was not routinely used in the postoperative course in this study. Baseline NSAID analgesics could be sufficient for the prevention of postoperative pain regardless of the short-term action of the epidural analgesic.[25] Less pain facilitated early mobilization. Moreover, Lassen et al. previously recommended the use of NSAID or acetaminophen oral multimodal analgesia in their guidelines for perioperative care for PD.[12] A revised ERAS protocol should include the use of NSAID or acetaminophen and earlier epidural catheter and urinary catheter removal. Another concerned was the removal of intra-abdominal drains. When comparing the previous reports and our present study, the removal of intra-abdominal drains was a trend to later in the present study. There is still debate on whether or not drains should be routinely placed following DP and their use is based on low-level evidence. A revised ERAS protocol should perhaps include earlier analysis of drain fluid amylase with the target of achieving earlier drain removal.

The overall median length of stay was 14 days. The median length of stay was longer than previous ERAS reports. This discrepancy could be explained by several factors. One possible reason was the late removal of intra-abdominal drains. A randomized controlled trial found that a prolonged period of drain insertion is associated with increased hospital stay in PD. The second possible reason was that physicians are reluctant to discharge DP patients early after surgery since major complications can even occur with some delay after surgery. In a recent study in patients undergoing colonic surgery, only half of the patients were discharged when all discharge criteria were met, and 43% of this group was kept in hospital because of surgeons' judgment. For this reason, several author advice to at least add data on time to recovery to the length of stay as the outcome of enhanced recovery after surgery programs.[26] The third possible reason was that medical system after discharge was different between Japan and other countries.

There were some limitations in this study. First, this was a retrospective single-center study with a relatively small sample size. A randomized controlled trial comparing ERAS with traditional care in DP would be the strongest way to assess the true effect of ERAS. However, this brings up ethical questions since the majority of ERAS protocol elements have been separately proven to be effective in randomized controlled trials and meta-analysis, and several ERAS protocol elements have now become standard care.[27] Second, our ERAS program did not include fluid management, which is one of the key elements of ERAS program. Third, most patients had good performance status. Patients with poor performance status (e.g. Eastern cooperative oncology group performance status ≥ 3, severe dementia, and swallowing difficulty) could not be treated in our hospital, because we specialize in cancer treatment. These could be selection bias.


 > Conclusion Top


This study showed the safety and feasibility of ERAS program following DP. However postoperative element, especially the removal of catcher and drain, was more challenging. Further modification of the protocol and additional education of patients and health professionals may help to improve recovery, shorten hospital stay, and enhance the return of normal function.

Acknowledgement

This work was supported, in part, by the Uehara Memorial Foundation and Takeda Science Foundation.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
 > References Top

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Richardson J, Di Fabio F, Clarke H, Bajalan M, Davids J, Abu Hilal M. Implementation of enhanced recovery programme for laparoscopic distal pancreatectomy: Feasibility, safety and cost analysis. Pancreatology 2015;15:185-90.  Back to cited text no. 14
    
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Murakawa M, Aoyama T, Asari M, Katayama Y, Yamaoku K, Kanazawa A, et al. The short- and long-term outcomes of radical antegrade modular pancreatosplenectomy for adenocarcinoma of the body and tail of the pancreas. BMC Surg 2015;15:120.  Back to cited text no. 15
    
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Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev 2011;(2):CD007635.  Back to cited text no. 16
    
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Werawatganon T, Charuluxanun S. Patient controlled intravenous opioid analgesia versus continuous epidural analgesia for pain after intra-abdominal surgery. Cochrane Database Syst Rev 2005;(1):CD004088.  Back to cited text no. 18
    
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20.
Balzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg 2008;95:1387-93.  Back to cited text no. 20
    
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    Tables

  [Table 1], [Table 2], [Table 3]



 

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