Impact of centraIization of pancreaticoduodenectomy coupIed with fast track recovery protocoI：a comparative study from India

Omar J Shah， Sadaf A Bangri， Manmohan Singh， Reyaz A Lattoo，Mohammad Y Bhat and Feroze A Khan

Kashmir， India

Impact of centraIization of pancreaticoduodenectomy coupIed with fast track recovery protocoI：a comparative study from India

Omar J Shah， Sadaf A Bangri， Manmohan Singh， Reyaz A Lattoo，Mohammad Y Bhat and Feroze A Khan

Kashmir， India

BACKGROUND： Fast track strategy in the management of patients undergoing intra-abdominal surgery of various types has emerged as a landmark approach to reduce surgical stress and accelerate recovery. This study was to evaluate the effect of fast track strategy on patients subjected to pancreaticoduodenectomy （PD） from an individual unit during transit from low to a high volume center.

METHODS： A total of 142 PD patients who had been subjected to fast track strategy between June 2008 and September 2012 were compared with 46 patients who had received conventional surgery between January 2006 and May 2008. Comparative analysis was made of postoperative complications， postoperative recovery， length of hospital stay and patient readmission requirement.

RESULTS： The patients subjected to fast track strategy had a faster recovery and a shorter hospital stay than those who were treated conventionally （7.8 vs 12.1 days）. The intraoperative events like operative blood loss （417.9±83.8 vs 997.4 ±151.8 mL，P＜0.001）， blood transfused （a median of 0 vs 1 unit， P＜0.001）and operative time taken （125 vs 245 minutes， P＜0.001） were significantly lower in the fast track group. The frequency of pancreatic fistula （4.9% vs 13.0%） and delayed gastric emptying （7.0% vs 17.4%） was also significantly reduced with fast track treatment. Nevertheless， the readmission rate （11.3% vs 6.5%） was found relatively higher within the fast track group. However， increased readmission rates in this study seem to be independent of fast track protocol.

CONCLUSIONS： This preliminary analysis suggests that the fast track approach might be beneficial to the well-being of the patients after PD， for it accelerates the immediate clinical recovery of patients and significantly shortens their length of hospital stay.

（Hepatobiliary Pancreat Dis Int 2016；15：546-552）

fast track recovery；

pancreaticoduodenectomy

Introduction

Pancreaticoduodenectomy （PD） is being universally performed with increasing frequency and decreasing mortality， both for benign and malignant lesions of the periampullary and pancreatic regions. Decreasing mortality of postoperative cases has been attributed to multiple factors including improved surgical technique， improved critical care， improved management of postoperative complications and， above all， the emergence of specialized centers of excellence （high volume centers） at regional levels.［1］With the decline in postoperative mortality， attention of surgical teams has shifted towards reducing the morbidity burden of patients by enhancing their postoperative recovery and reducing their hospital stay. To realize this objective and to provide optimum pain relief and stress reduction to patients through regional anesthesia，［2］fast track management programs were introduced. Encouraging results with fast track programs after PD have been reported elsewhere.［3-5］Kennedy et al［3］retrospectively reviewed the outcome of 135 consecutive PDs， classified in two groups： a “post-pathway group” of 91 patients， who underwent PD after implementation of a clinical pathway and a “pre-pathway” group consisting of 44 patients. During the post-pathway period， a higher volume ofoperations was undertaken （mean 7.6 cases/month）compared to the previous period （2 cases/month）， which reflected a centralization of pancreatic services in that hospital. Significantly shorter operative time， shorter postoperative length of stay， and less hospital charges were documented during the post-pathway period.［3］

The Department of Surgical Gastroenterology at Sher-i-Kashmir Institute of Medical Sciences in Srinagar，Kashmir （India） is a regional center of reference for pancreatic surgery. Our single team at this center introduced fast track strategy for PD soon after acquiring adequate skills and experience in the area and evolved a focused approach to achieve its objectives. This study on the fast track strategy in PD is based on our observation in this field from January 2006.

Methods

Patients

The material for this study was obtained from the records of the 188 patients who had been subjected to PD from January 2006 to September 2012. These patients were divided into 2 groups： the fast track group comprising 142 patients， treated between June 2008 and September 2012 by a single team headed by a senior pancreatic surgeon； and the conventional group consisting of 46 patients treated between January 2006 and May 2008 by three pancreatic surgeons. No change was introduced in the perioperative approach with regard to analysis and perioperative infusions over the years. Patients were treated in an intensive care unit setting for 12 to 24 hours，unless further monitoring was indicated. Analgesia requirements were monitored in both groups by a dedicated anesthetic pain service team. Analgesia was induced intravenously with a loading dose of 5 mg morphine，and subsequently the intravenous patient-controlled analgesia pump was programmed to provide 1.5 mg morphine boluses intravenously as needed. Intravenous paracetamol or nonsteroidal anti-inflammatory drugs（NSAIDs） were supplemented when required. In order to quantify the severity of postoperative pain， the patients were asked to use the 10 cm visual analogue scale （VAS）graded from 0 （no pain） to 10 （unbearable pain）. The VAS score was recorded daily at rest after coughing at regular interval， during the first 5 days after surgery. Oral non-opoid medication or paracetamol was used once the bowel function recovered.

Surgical procedures

The patients who had periampullary malignant lesions were exclusively treated by pylorus preserving pancreaticoduodenectomy （PPPD） （i.e.， resection complete； nodal groups resected including the anterior and posterior pancreaticoduodenal lymph nodes， nodes in the lower hepatoduodenal ligament and along the right lateral aspect of superior mesenteric vessels）. Operative time was defined as the time between the incision and final closure. Operative blood loss was estimated according to suction reservoir volume and sponge weight.

The fast track protocol （Table 1） started with preoperative counselling and included early oral feeding and standardized early postoperative mobilization of patients. In the fast track group， pancreaticojejunostomy using a two layer invagination type anastomosis was performed in all patients， whereas in the conventional group， pancreaticojejunostomy was performed by a duct to mucosa method in 34 patients and by a two layer invaginationmethod in 12 patients depending on surgeon's preference. Pyloric sphincter dilatation before antecolic duodenojejunnal anastomosis was performed in all patients；serial metal dilators of 28-34 mm in diameter were used for pyloric dilatation starting with 28 mm for 1 minute with a gradual increase of 2 mm. No prokinetic drug or octreotide was given routinely. A proton pump inhibitor（PPI） was administered intravenously after surgery and was replaced by oral therapy once diet was tolerated. This treatment continued for at least 2 weeks after discharge. Pancreatic enzyme supplements were prescribed after intake of soft diet； this was continued postoperatively with the dosage being adjusted according to the symptoms. Serum glucose levels were closely monitored postoperatively. Prophylaxis consisted of a prescription of low molecular weight heparin and a single dose of antibiotics （piperacill in+tazobactam， 4.5 g）. The patients were discharged when they fulfilled all the discharge criteria （Table 1）.

Table 1. Patient management protocol for the fast track group

Most of the patients in the conventional group underwent feeding jejunostomy based on surgeon's preference instead of preoperative nutritional assessment. The traditional postoperative protocol comprised nasogastric decompression till day 5， liquid drinks from day 6 and solid food from day 7. There was no established policy for patient mobilization. Abdominal drain was placed adjacent to pancreatic and biliary anastomoses in both groups.

Postoperative measures

Preoperative， intraoperative and postoperative data were collected from the records of the two groups. The data were analyzed comparatively to assess the treatment of the two groups and the selective approach used in the fast track group. Any measurable amount of drainage fluid with amylase， three times the normal serum level on or after third postoperative day， indicated a pancreatic fistula defined by the International Study Group on Pancreatic Fistula （ISGPF）.［6］Inability of a patient to return to a standard diet by the end of the first postoperative week， necessitating prolonged nasogastric intubation of the patient， was treated as delayed gastric emptying（DGE） defined by ISGPF.［7］Bile leakage was defined as a bilious drain with increased bilirubin level and culture positive purulent collection was treated as an intraabdominal abscess. Wound infection was pronounced as per surgical site infection （SSI） guidelines.［8］The length of hospital stay of the patients ranged from the first postoperative day to the discharge. Death occurring during the hospital stay or within 30 days of surgery was considered as an operative mortality. The study focused on the occurrence of pancreatic fistula， DGE， length of hospital stay， patient readmission rate， and mortality.

Statistical analysis

Statistical analyses were performed using the SPSS（version 20， SPSS Inc.， Chicago， IL， USA）. The statistical data were analyzed using Student's independent t test，Wilcoxon's rank-sum test， and the Mann-Whitney U test. A P value of less than 0.05 was considered statistically significant.

Results

Demographic data

The age and gender distribution of patients was similar in the two groups （Table 2）. There were 84 male and 58 female patients in the fast track group and 30 male and 16 female patients in the conventional group. The age of patients ranged between 42 and 82 years （mean 61.9）in the fast track group， and between 42 and 80 years（mean 59.1） in the conventional group. The two groups of patients were alike in age， gender distribution， BMI，American Society of Anesthesiologists （ASA） score， serum albumin and bilirubin values.

Co-existing abnormalities between the two groups at the preoperative stage included cholangitis， biliary stenting，cardiovascular abnormality and diabetes （Table 2）. There was no statistical significance between the two groups.

Operative and postoperative results

The location， texture and pancreatic duct diameter of the tumor were similar in both groups （Table 3）. Intraoperative details including operative blood loss， blood transfused， operative time， patients needing intraoperative blood transfusion and patients on feeding jejunosto-my were statistically significant between the two groups（P＜0.001， Table 3）. Postoperative details about removal of nasogastric tube， intake of oral liquids and normal diet， removal of drains， and length of postoperative hospital stay were statistically significant between the two groups （P＜0.001， Table 4）.

Table 2. Patients characteristics/co-existing abnormalities

Complications

Postoperative complications in the two groups included respiratory， cardiovascular， neurological and thromboembolic diseases， bile leakage， intra-abdominal abscess， wound infection， DGE， and the formation of pancreatic fistula （Table 5）. The frequency of these complications in the two groups was statistically insignificant except for DGE （7.0% vs 17.4%）， which was significantly lower in the fast track group， and the formation of pancreatic fistula （4.9% vs 13.0%）， which was marginally significant （P=0.059）. However， the readmission rate was higher in the fast track group （11.3% vs 6.5%， Table 5）due to complications like wound infection （31.3%） and intra-abdominal abscess （18.8%）. Similar results were observed in the conventional group. The total readmission rate was 50% in the fast track group and 66.7% in the conventional group within the first 7 days （immediate readmissions） （Table 6）. About 68.8% of the patients in the fast track group were re-admitted in the hospitalfor over 7 days in contrast to 100% of the patients in the conventional group. Four patients in the fast track group were treated by percutaneous catheter drainage （PCD），whereas one patient in the conventional group received PCD. One patient in the fast track group required relaparotomy for drainage of an intra-abdominal abscess. The remaining patients were treated conservatively with success.

Table 3. Tumor relevant information with intraoperative details

Table 4. Postoperative details

Table 5. Postoperative complications， morbidity and mortality profile （n， %）

Table 6. Details of readmissions

Discussion

Fast track protocol has been used in colorectal，［9］gastroesophageal，［10］musculoskeletal［11］and aortic surgical procedures，［12］but it is limited in pancreatic surgery. Our results of fast track pancreatic surgery have been encouraging. Despite the possible selection bias due to historical controls， the two groups in our study were similar in demographic and perioperative factors. The senior pancreatic surgeons were stable overtime， with three senior pancreatic surgeons in the conventional period and one in the fast track period. The volume of PD increased from an average of 15 per year in the conventional group to around 28 per year in the fast track group， indicating the presence of a learning curve. As the study progressed， there was an appreciable predisposition towards decreased blood loss， decreased operative time and decreased need for blood transfusion. Schmidt et al［1］reported that surgeons with less experience （＜50 PDs） performed PD with a higher morbidity， a higher pancreatic fistula rate， a larger volume of estimated blood loss and longer operative time compared with surgeons with more experience （＞50 PDs）. Similar findings were reported by Kennedy et al.［3］Patients undergoing PD， experienced perioperative care， early recognition and appropriate management of postoperative morbidity were carefully selected through frequent repetition. Thus，a higher volume of operations was undertaken in the fast track period compared with the conventional period， indicating a centralization of pancreatic services in this institution. Similarly， Ansari et al［13］reported the transfer of patients to a high volume pancreaticoduodenectomy center and the decreased morbidity and mortality. Decreased blood loss due to meticulous surgical technique（minimizing blunt dissection， ensuring intraoperative hemostasis and maintaining normothermia） is probably a practical measure which can be used to reduce postoperative morbidity. Extensive loss of blood during surgery increases surgical stress and also entails the need for blood transfusion， both of which have been shown to exert an immunosuppressive effect and to increase postoperative morbidity like septic complications.［14，15］Extended operative duration has also been identified to negatively influence outcomes after pancreatic resections. Both increased rate of infectious complications and longer duration of hospital stay have been well documented to correlate with longer operative time.［16］The reasons for the decline in morbidity and mortality could be multifactorial， such as increase in surgeon's volume and institutional volume， which involves improved technical skills of the operating surgeon， more care in patient selection criteria， better perioperative and intensive care units， and an improved multidisciplinary attention.

Traditionally， the postoperative management of patients undergoing abdominal surgery involves the use of nasogastric tube and the avoidance of oral intake of liquid or solid food until the resolution of the ileus. The extended use of the nasogastric tube has been questioned due to lack of scientific evidence. Complications like fever， atelectasis and pneumonia are more frequent in patients with extended use of the nasogastric tube， and bowel function is recovered earlier if nasogastric decompression is avoided.［17］Early removal of the nasogastric tube may also improve mobilization and reduce the rate of complications.［17，18］

The nasogastric tube was successfully removed onthe first postoperative day in 91.5% of our cases which is comparable to 95.0% reported by Nikfarjam et al.［19］In our study， the percentage of nasogastric tube removal increased to 93.0% by the third postoperative day， which is similar to 95.6% reported by Balzano et al.［20］Early removal of nasogastric tube followed by early postoperative feeding has been found to preserve integrity of the gut mucosa， reduce bacterial translocation， stimulate host-defense mechanism and improve postoperative outcome.［21］Early postoperative feeding also improves gastric emptying by initiating a forceful peristaltic wave of contraction.［22］An extensive Norwegian investigation on patients after upper gastrointestinal and hepatopancreatic biliary surgery also demonstrated that early oral feeding was both safe and feasible.［23］

DGE， a frustrating postoperative event， occurs in 20%-30% of cases.［24］This is a temporary condition that improves with time， but not without interrupting enteral nutrition， which may be deleterious in malnourished patients. Mechanical pyloric dilation is a simple and fast method to solve the DGE problem.［25］The lower percentage of DGE in the fast track group （7.0%） in our series may be in part due to pyloric muscle dilatation performed as a constituent of fast track method. While reporting a significant reduction in DGE in the fast track group versus the traditional group （13.9% vs 24.6%），Balzano et al［20］attributed it to early postoperative feeding and early mobilization which increases peristalsis of the stomach and small intestines， thereby facilitating gastric emptying. Moreover enhanced recovery after surgery（ERAS） protocol has been shown as independent factor in a multivariate analysis in reducing DGE.［25］However，early mobilization has little effect on the postoperative ileus［26］and has a secondary role in reducing DGE.

Pancreatic resection has been considered as a high risk procedure contributing to higher morbidity and mortality of patients. Postoperative problems like DGE，pancreatic fistula and biliary complications are contributable to prolonged hospital stay. Fast track surgery is to improve the postoperative outcome by reducing hospital stay and readmission rate. Improved surgical procedures in high volume centers have reduced operative mortality to 5%， whereas the mortality remains 10% in low volume hospitals. The overall morbidity is still around 50%-60%.［27，28］In our study， the frequency of intraabdominal complications was similar in the two groups. However， the incidence of pancreatic fistula was significantly lower in the fast track group （4.9%） than in the conventional group （13.0%）.

The disadvantage of fast track surgery is the higher readmission rate. Rosemurgy et al［29］reported readmission after PD was due to nausea/ vomiting （20%）， abdominal pain （18%） and wound infection （15%）. But Balzano et al［20］reported that there was no increase in the readmission rate in the fast track group versus the conventional group （7.1% vs 6.3%）. In our study the readmission rate was higher in the fast track group than in the conventional group （11.3% vs 6.5%）. This higher readmission rate was due to infective complications as reported elsewhere.［19］

Etiological analysis revealed that about 50% of readmissions were ascribed to infective complications rather than the application of fast track method. Nikfarjam et al［19］recorded a higher readmission rate in the fast track group （15%） than in the conventional group， which may be due to the application of fast track protocol.

With the pressure to reduce the length of hospital stay，we worry about early discharge that just leads to more readmissions. Some patients seem to be ready for discharge when they are tolerating a regular diet， but in fact they have persistent food aversion or disinterest falling short of the diagnosis of DGE. Similarly， wound infection or subclinical pancreatic fistula may be missed. These patients are quick bouncebacks and if detected early the scenario can be prevented by a few days of extra hospital stay during the first admission. Thus if such patients can be detected， the readmission rate can be reduced substantially （Table 6）. Presumably， these are patients in whom the consequences of complications are not anticipated.

The major advantage of the fast track protocol was the significantly decreased postoperative length of hospital stay or the discharge rate of patients on the 8th postoperative day （77.5%） being higher than that （8.7%） of patients treated with the conventional approach. Shorter hospital stay can be attributed to the decrease in DGE and to the effect of the fast track protocal on patients with no complications， improved digestive function， and earlier mobilization. Reduced postoperative hospital stay due to the improved approach has far reaching economic benefits， which are highly significant in the Indian context.

In conclusion， fast track protocol after PD contributes to better patient management. The protocol is safe and feasible， enhances gastric emptying which enables a short nasogastric intubation and a short hospital stay. Increased readmission rate in our study seems to be independent of fast track protocol.

Acknowledgements： We thank Rayees A Dar， Statistician SKIMS，for providing the statistical analysis for this paper.

Contributors： SOJ proposed the study. SOJ， BSA and SM performed the research and wrote the first draft. LRA， BMY and KFA collected and analyzed the data. All authors contributed to the design and interpretation of the study and to further drafts. SOJ is the guarantor.

Funding： None.

Ethical approval： This study was approved by the Institutional Ethics Board of our hospital.

Competing interest： No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.

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December 19， 2014

Accepted after revision February 1， 2016

Author Affiliations： Department of Surgical Gastroenterology， Sher-i-Kashmir Institute of Medical Sciences， Srinagar， Kashmir， India （Shah OJ，Bangri SA， Singh M， Lattoo RA， Bhat MY and Khan FA）

Omar J Shah， MS， FICS， Kral-Sangri， Brein， Nishat，Srinagar， Kashmir， India （Tel： +194-2401013ext2189； Fax： +194-2403470；Email： omarjshah@yahoo.com）

? 2016， Hepatobiliary Pancreat Dis Int. All rights reserved.

10.1016/S1499-3872（16）60093-0

Published online May 9， 2016.