Gastroenterology

Gastroenterology

Volume 141, Issue 1, July 2011, Pages 157-163.e1
Gastroenterology

Original Research
Clinical—Pancreas
Enteral and Parenteral Nutrition in the Conservative Treatment of Pancreatic Fistula: A Randomized Clinical Trial

https://doi.org/10.1053/j.gastro.2011.03.040Get rights and content

Background & Aims

Postoperative pancreatic fistula is the most common and potentially life-threatening complication after pancreatic surgery. Although nutritional support is a key component of conservative therapy in such cases, there have been no well-designed clinical trials substantiating the superiority of either total parenteral nutrition or enteral nutrition. This study was conducted to compare the efficacy and safety of both routes of nutritional intervention.

Methods

A randomized clinical trial was conducted in a tertiary surgical center of pancreatic and gastrointestinal surgery. Seventy-eight patients with postoperative pancreatic fistula were treated conservatively and randomly assigned to groups receiving for 30 days either enteral nutrition or total parenteral nutrition. The primary end point was the 30-day fistula closure rate.

Results

After 30 days, closure rates in patients receiving enteral and parenteral nutrition were 60% (24 of 40) and 37% (14 of 38), respectively (P = .043). The odds ratio for the probability that fistula closes on enteral nutrition compared to total parenteral nutrition was 2.571 (95% confidence interval [CI]: 1.031–6.411). Median time to closure was 27 days (95% CI: 21–33) for enteral nutrition, and no median time was reached in total parenteral nutrition (P = .047). A logistic regression analysis identified only 2 factors significantly associated with fistula closure, ie, enteral nutrition (odds ratio = 6.136; 95% CI: 1.204–41.623; P = .043) and initial fistula output of ≤200 mL/day (odds ratio = 12.701; 95% CI: 9.102–47.241; P < .001).

Conclusions

Enteral nutrition is associated with significantly higher closure rates and shorter time to closure of postoperative pancreatic fistula.

Section snippets

Trial Design and Participants

This parallel randomized clinical trial was carried out at a university-based surgical department specializing in gastrointestinal surgery to evaluate the effects of 2 regimens of nutritional support on the closure rate of POPF (ClinicalTrials.gov number NCT01025414). The study was carried out after the international ethical recommendations stated in the Declaration of Helsinki. The Bioethics Committee of Jagiellonian University approved the protocol of this trial and all the patients gave

Patient Population

Between September 2006 and October 2009, a group of 91 patients was initially screened to participate in the study. Thirteen patients were subsequently excluded and the remaining 78 subjects were allocated into study groups receiving enteral nutrition (n = 40) and parenteral nutrition (n = 38). Reasons for exclusion were abdominal abscess requiring interventional treatment (n = 6), severe malnutrition requiring combined nutritional treatment (n = 3), declining to participate (n = 3), and other

Discussion

The evidence-based approach to postoperative pancreatic fistulas is limited due to the paucity of randomized-clinical trials recruiting adequate numbers of patients. Nevertheless, fasting with nutritional support, adequate drainage, and skin protection are currently the basic aspects of treatment.3, 4, 15 Conservative therapy is preferred for low-output, uncomplicated fistulas, while those persisting for 6–8 weeks and associated with septic complications usually require a more aggressive

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    This article has an accompanying continuing education activity on page e19. Learning Objective: Upon completion of this CME exercise, successful learners will be able to recommend treatment method in case of postoperative pancreatic fistula.

    Conflicts of interest The authors disclose the following: Dr Klek received educational and research grants from Nutricia Ltd, Fresenius Kabi Ltd, and BBraun Company. The remaining authors disclose no conflicts.

    Funding Supported by a research grant from Nutricia Ltd (2006–2009). The funding source did not participate in study design, collection, analysis, or interpretation of the data, or writing of the report. The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and analysis.

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