Journal of Digestive Diseases and Hepatology (ISSN: 2574-3511)

Article / Research Article

"Preliminary Data on Tolerability and Feasibility of Specific Stepwise Diet Protocols in Patients Undergoing Pancreaticoduodenectomy"

Sara Emerenziani1*,Michele Pier Luca Guarino1,Sergio Valeri2,Chiara Cascone2, Silvia Cocca1, Laura Maria Trillo Asensio1,Antonio Giordano1, Michele Cicala1, Sergio Morini3,Roberto Coppola2

1Gastroenterology Unit, University Campus Bio-Medico of Roma, Italy

2Surgery Unit, University Campus Bio-Medico of Roma, Italy

3Laboratory of Microscopic and Ultra Structural Anatomy, University Campus Bio-Medico of Roma, Italy

*Corresponding Author:Emerenziani S,Department of Digestive Disease of Campus Bio Medico University of Rome, Via Alvaro del Portillo 200, 00100 Roma, Italy, Tel: +39 06225411;Fax: +39 0622541456; E-mail: s.emerenziani@unicampus.it.

Received Date: 31 January, 2017; Accepted Date: 24 March, 2017; Published Date: 31 March, 2017.

 

Background: The number of patients undergoing Pancreaticoduodenectomy (PD) has increased dramatically in the last decades and at the same time, outcomes have improved.Among thepostoperative complicationsDelayed Gastric Emptying (DGE) is one of the most troublesome. Enhanced Recovery After Surgery(ERAS) pathway is an interdisciplinary model, aimed to safely manage post-operative recovery being the possibility to early resume an oral feeding a key concept.

Aim: The aim of the present study is to assess the feasibility and tolerability of a specific diet protocol following PD.

Patients and methods:27consecutive patients, who underwent a PD at the Campus Bio-Medico University of Rome, between January 2014 and December 2015, wereenrolled. All patients started an early oral feeding on postoperative day 2 with a specific diet protocol characterized by a progressively increasing amount of calories, from405 kcal to a maximum of 1770 kcal (DCP I-VI).

  • All patients started an early oral feeding on postoperative day 2. 17 of27 patients (63%) were able to complete the full diet protocol (form DCP II to DCP VI) without anyinterruption (fully compliantpatients),whereas 5 patients (18%), completed the diet protocol in 9±2 days (partially compliant patients). Five patients (18%) developed a DGE. On the day of discharge, 4 out of 27 patients (15%) received an oral nutritional supplement. Mean length of hospital stay was 14.2±6.2 days: 11.4±4 days in fully compliant patients, 17.2±3 days in partially compliant patients and 20.8±8.8 days in non-compliant patients. Fully compliant patients showed a mean length of hospital stay significantly shorter than partially compliant and non-compliant patients (p<0.01).
  • The results coming from this pilot study show that early oral feeding in our series of patients undergoing PD is feasible, safe and well tolerated. Further studies on a larger series of patients are needed in order to confirm our preliminary findings and to assess the impact of early oral feeding compliance on the long-term outcome.

Keywords:PancreaticOduodenectomy;  Delayed Gastric Emptying; Enhanced Recovery After Surgery; Diet; Protocols

Introduction

The number of patients undergoing PancreaticOduodenectomy (PD) has increased dramatically in the last decades and at the same time, outcomes has improved. Postoperative mortality rates have significantly decreased thanks to centralization policies advances in surgical technique, perioperative care and multidisciplinary management of complications[1]. However, even in high-volume centers such as institutions performing more than 15-20 pancreatic resections per year, patients still experience significant postoperative morbidity and full recovery after surgery takes longer than expected[2]. Among the postoperative complications the most prevalent are the pancreatic fistula, the intra-abdominal complications, such as abscess, and the syndrome of Delayed Gastric Emptying (DGE)[2].

DGE is one of the most troublesome postoperative complications after PD and occurs in nearly 30% of thepatients. The available definition of DGE is based on the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient[3]. Moreover, the presence of DGE has been related to prolonged hospital stay, increasing costs and impaired quality of life. The relationship between postoperative complications and the occurrence ofDGE has not been fully understood yet, although local inflammation or the presence of abscesses was hypothesized to be the main causes of the delayed gastric motility[4]. Notwithstanding that DGE is mostly related to postoperative complications, a subgroup of patients can develop a primary or pure DGE in the absence of other complications[2].

Enhanced Recovery after Surgery(ERAS) is an interdisciplinary multimodal concept designed to accelerate postoperative recovery: morbidity is reduced and patients recovery is improved by decreasing surgical stress, obtaining good pain control,early resumingoforal feeding and mobilization;consequently the Length-Of-Stay In Hospital (LOSH) and costs are significantly reduced[5]. It has been demonstrated that early postoperative oral feeding may be an additional toolto improve gastric emptying. While fasting impairs the peristaltic activity of the stomach and small intestine, the fed state seems to be characterized by more effective peristaltic waves. In this light, a previous study showed that a fast-track program following PD (oral feeding on the day 4 after surgery) improves gastric emptying and reduces postoperative stay[6]. Although growing evidence suggests an implementation of the fast trackprogram, allowing patients to resume oral feeding on day 2 after surgery, to date, there are only few available data concerning the compliance to early oral feeding and the rate of patients achieving dietary goals after PD[7]. Therefore, the aim of the present study is to assess the feasibility and tolerability of a specific diet protocol following PD.

Patients and method

From January 2014 and December 2015, 27 consecutive patients underwent the protocol of early oral feeding following PD as shown in (Table 1).

  1. Diet Protocol: All patients started an early oral feeding on postoperative day 2 with a specific stepwise diet protocol characterized by a progressively increasing amount of calories, from405 kcal to a maximum of 1770 kcal namely DCP II to DCP VI (Table 1). The protocol also provided a gradual increase of lipids, proteins,fibers and lactose.Compliance to diet protocol was monitored by a food diary recording system, administered by an expert dietitian. The total amount of calories of each diary was calculated by a dedicate software (Sapermangiare.mobi). Patients were allowed to switch the following diet protocolsif they were able to eat at least 75% of the prefixed calories.
  2. Surgical procedure: Incidence of postoperative complications, such as DGE (according to the definition proposed in a previous study[3],abdominal abscess and pancreatic fistula (according to definition of the International Study Group on Pancreatic Fistula (ISGPF)[8], was monitored. The occurrence of DGE was defined as primary, in the absence of other complications, and secondary, when associated with abdominal abscess, pancreatic fistula or other postoperative complications. In the postoperative setting, the nasogastric tube was removedon day 1 after PD and an early mobilizationprogram was appliedin all patients.Data were collected prospectively in a database and analyzed retrospectively. Surgery was performed by the same surgeon, using a right subcostal incision extended to the left side. When possible, a pylorus-preserving pancreaticoduodenectomywas performed, with standard lymphadenectomy. During surgery a biliary culture was collected for microbiological examination.The reconstructive phase provided pancreatico-jejunostomy, biliary-jejunostomy and, finally,an anti-colic duodenal-jejunostomy (or gastro-jejunostomy in case of Whipple’s procedure). Two surgical drains were placed: the right one near the biliary-jejunostomy and pancreaticojejunostomy and the left one near the duodenal- and front of the pancreaticojejunostomy. A nasogastric tube wasroutinely placed.Analgesia was obtained by morphine (10 mg) and Ketorolac (60 mg), whether not contraindicated. No prokinetic agentswere administered.
  3. Statistical analysis: Values are expressed as means ± SEM. The unpaired‘t’ test was used to compare differences between groups. A p value < 0.05 was considered to be significant.
  4. Results

 

Demographics and intra-operative parameters

Demographic and clinical characteristics of patients who underwent PD, included in the present analysis, are displayed in (Table 2)

A Pylorus-Preserving PD (PPPD) was performed in 17out of 27 patients (63%), whereas Whipple procedure was performed in 10 patients (37%).The average duration of surgery was 384minutes and the median intraoperative blood loss was approximately 350 ml.

Compliance to stepwise oral feeding protocol

In 27 out of 27 patients (100%)the nasogastric tube was removed on the first postoperative day. All patients were allowed to take clear fluids on day 1 and theywere able to resume oral feeding on the second postoperative day. Seventeen out of 27 patients (63%) were able to complete the entire diet protocol (form DCP II to DCP VI) without anyinterruption (fully compliant patients),whereas 5 patients (18%), completed the diet protocol in 9±2 days (partially compliant patients). Five patients (18%) developed a DGE andstarted therefore anenteral nutrition (not compliant patients). On the day of discharge, 4 out of 27 patients (15%) received an oral nutritional supplement added to their oral feeding, in order to achieve 95% of prescribed calories.

Patientscharacteristics according to compliance to diet protocol are shown in (Table 3).

Clinical outcome

Overall mean length of hospital stay was 14.2±6.2 days: 11.4±4 days in fully compliant patients, 17.2±3 days in partially compliant patients and 20.8±8.8 days in non compliant patients. Fully compliant patients showed a mean length of hospital stay significantly shorter than partially compliant and non-compliant patients (p<0.01).

The occurrence of postoperative complications is displayed in (Table 4).The overall mortality rate was 3%. The occurrence of secondary DGE was related to the presence of one major surgery complication in all cases. None of ourpatients presented a primary DGE.

Discussion

ERAS (Enhanced Recovery After Surgery) program represents an interdisciplinary model, designed to safely manage postoperative recovery with a positive modulation of stress response[3]. A key component of ERAS protocol is the possibility to early resume an oral feeding after surgery, being pre or postoperative artificial nutrition not recommended[3,9-11]. Perioperative nutritional support in pancreatic cancer patients is still under debate. Despite in theERAS pathway patients are allowedto resume oral feeding soon after PD, it should be also recommended to strictly monitor their compliance [12].Preliminary results from this pilot study show that early oral feeding withadhocstepwise protocol is feasible and well tolerated by the majority of patients undergoing PD. In our group of patients, a clear fluids diet was prescribed from the first postoperative day and a stepwise diet protocol was administered thereafter, with a compliance of 90%. The high compliance rate, reported in this study, is in line with previous articles[4,7]and could be explained with the customized preoperative counseling that is routinely performed in our hospital. Indeed, it has been demonstrated that preoperative counseling contributes to alleviate fear and anxiety; moreover it is a good chance to communicate the importance of achieving daily targets before and after surgery[10]. In addition, our patients underwent nutritional counseling by an expert dietitian who explained each step of postoperative oral feeding protocol in detail. This approach was also enhanced by daily counseling during hospitalization. Compliance to early oral feeding was significantly associated with an early discharge from the hospital, thus representing a sign of total functional recovery.

A large body of evidence supports the pivotal role of nutritional and metabolic alterations before surgery in determining the incidence of adverse events and the impairment of surgery-related outcome[13]. The nutritional interventions made in the perioperative period can be crucial in improving the clinical outcome of patients with cancer [14], indeed malnutrition is a preventable andpossibly treatable condition[15]. As far as concern the caloric requirement, it is well known that eating enough tomeet nutritionaltargets is crucial in order to prevent and/or treat malnutrition:weight loss is frequently observed in cancer patients, even in an early disease stage and, when present, it is associated with a negative clinical outcome[14,16]. Therefore, it appears mandatory to ensure the achievement of caloric requirements in these patients, either with an oral diet or with the use of oral nutritional supplements, when required as part of the nutritional and metabolic support of the patient’s cancer journey[17].

The presence of postoperative complications is the most significant risk factor for DGE, as supported by a recent evidenceshowinga significant correlation between the incidence of DGE and the presence of pancreatic fistulas [2,3]. The mechanismunderlying postoperative gastro paresis, gastric stasis and DGE are still poorly understood[5,6].Treatment with prokinetic drugs such as erythromycin, a motilinreceptor agonist,was shownto reduce the incidence of DGE, supporting thehypothesis that duodenal resection, and postoperativedecrease in plasma motilin levels may be possible triggers of DGE[2,18].Even if the occurrence of DGE is mostly related to other postoperative complications,a subset of patients can develop a primary or pure DGE[2].In our series of patients, DGE was developed only in the presence of other complications such as a pancreatic fistula, while no primary DGE was observed.

The possible major limitations of the present study are represented by the small sample size, the lack of a control group and the absence of a long-term clinical follow-up.

In conclusion, our results coming from this pilot study show that early oral feeding in our small series of patients undergoing PD is feasible, safe and well tolerated. The amount of oral intake needs to be strictly monitored; moreover, it must be emphasized that selected subgroups of patients undergoing PD could benefit from an artificial nutritional support.

 


 

Postoperative day

 

II

 

III

 

IV

 

V

 

VI

Kcal

405

640

1200

1580

1770

Proteins (g)

9

36

61

72

84

Lipids (g)

2

6

29

42

45

CHO (g)

90

103

185

241

274

Fibers (g)

2

3

6

14

18

Table 1: Diet protocols.

 

 

Demographic characteristics

 

Study Group (n=27)

Mean age (years ±DS)

65 ±10

Female number (percentage)

13 (48%)

Diagnosis

 

Pancreatic cancer

17

Periampullary cancer

8

Chronic pancreatitis

2

Clinical characteristics

 

Preoperative jaundice

6 (22%)

Preoperative diabetes

3 (11%)

BMI (mean±DS)

24±3.9

n (%) of patients with preoperative weight loss >5%

11 (40%)

Table 2: Demographic and Clinical characteristics of patient.

 

 

 

Fully compliant

 

Partially compliant

 

Non compliant

n

17

5

5

Age (Mean± SD)

64±10

70±12

69±7

BMI (Mean± SD)

24±4

26±1

24±4

Preoperative diabetes n (%)

2 (13%)

0 (0%)

1(25%)

Preoperative weight loss >5%

4 (23%)

2 (40%)

5 (100%)

Table 3: Characteristics of the patientsaccording to compliance to diet protocol.

 

 

 

Study Group (n= 27)

Overall mortality

1 (3%)

Morbidity

18 (66%)

Relaparotomy (deaths excluded)

1 (3%)

Percutaneous drainage (deaths and relaparotomy excluded)

5 (18%)

Access

10 (37%)

Pancreatic Fistula

 

Type A

10

Type B

2

Type C

1

DGE

 

Total

5/27 (19%)

Primary

0

Secondary

5/5 (100%)

Table 4: Occurrence of postoperative complications.

 

 

  1. Pecorelli N, Nobile S, Partelli S, Cardinali L, Crippa S, et al. (2016) Enhanced recovery pathways in pancreatic surgery: State of the art. World J Gastroenterol22: 6456-6468.
  2. Riediger H, Makowiec F, Schareck WD, Hopt UT, Adam U (2003) Delayed gastric emptying after pylorus-preserving pancreatoduodenectomy is strongly related to other postoperative complications. J GastrointestSurg 7: 758-765.
  3. Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, et al. (2007) Delayed Gastric Emptying (DGE) after pancreatic surgery: a suggested definition by theInternational Study Group Of Pancreatic Surgery (ISGPS).Surgery142: 761-768.
  4. Hanna MM, Gadde R, Allen CJ, Meizoso JP, Sleeman D, et al. (2016) Delayed gastric emptying after pancreaticoduodenectomyJ Surg Res202: 380-388.
  5. Lassen K, Coolsen MME, Slim K, Carli F, de Aguilar-Nascimento JE, Schäfer M, et al. (2012) Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS®) Society recommendations. ClinNutrEdinbScotl31: 817-830.
  6. Robertson N, Gallacher PJ, Peel N, Garden OJ, Duxbury M, et al. (2012) Implementation of an enhanced recovery programme following pancreaticoduodenectomy. HPB14: 700-708.
  7. Zouros E, Liakakos T, Machairas A, Patapis P, Agalianos C, et al. (2016) Improvement of gastric emptying by enhanced recovery after pancreaticoduodenectomyHepatobiliary Pancreat Dis Int 15: 198-208.
  8. Liang TB, Bai XL, Zheng SS (2007) Pancreatic fistula after pancreaticoduodenectomy: diagnosed according to International Study Group Pancreatic Fistula (ISGPF) definition. Pancreatology7: 325-331.
  9. Bond-Smith G, Belgaumkar AP, Davidson BR, Gurusamy KS (2016) Enhanced recovery protocols for major upper gastrointestinal, liver and pancreatic surgery. Cochrane Database Syst Rev 2:CD011382.
  10. Wind J, Polle SW, Fung KonJin PHP, Dejong CHC, von Meyenfeldt MF, et al. (2006) Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg93: 800-809.
  11. Fearon KCH, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CHC, et al. (2005) Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. ClinNutrEdinbScotl24: 466-777.
  12. Lassen K, Dejong CH, Revhaug A, Fearon K, Lobo DN, et al. (2015) Food at will afterpancreaticoduodenectomies. Re. ‘Perioperative nutritional support of patients undergoing pancreatic surgery in the age of ERAS’. Nutrition31: 1057-1058.
  13. Garcia GH, Fu MC, Dines DM, Craig EV, Gulotta LV (2016)Malnutrition: a marker for increased complications, mortality, and length of stay after total shoulder arthroplasty.J Shoulder Elbow Surg25: 193-200.
  14. Bozzetti F, Mariani L (2014) Perioperative nutritional support of patients undergoing pancreatic surgery inthe age of ERAS.Nutrition 30: 1267-1271.
  15. Muscaritoli M, Molfino A, Lucia S, Rossi Fanelli F(2015) Cachexia: a preventablecomorbidity of cancer. A T.A.R.G.E.T. approach. Crit Rev OncolHematol94: 251-259.
  16. Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME (2004)Cancer: disease and nutrition are key determinants of patients’ quality of life. Support Care Cancer 12: 246-252.
  17. Muscaritoli M, Molfino A, Gioia G, Laviano A, Rossi Fanelli F (2011) The ‘parallel pathway’: a novel nutritional and metabolic approach to cancer patients. Intern Emerg Med6: 105-112.
  18. Yeo CJ, Barry MK, Sauter PK, Sostre S, Lillemoe KD,et al. (1993) Erythromycin accelerates gastric emptying after pancreaticoduodenectomy. A prospective, randomized, placebo-controlled trial.218:229-237.

 

Citation:Emerenziani S, Luca Guarino MP, Valeri S, Cascone C, Cocca S, et al. (2017) Preliminary Data on Tolerability and Feasibility of Specific Stepwise Diet Protocols in Patients Undergoing Pancreatic Oduodenectomy. J Dig Dis Hepatol 2017: JDDH-126.