Intervention Protocol

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Nasogastric versus nasojejunal tube feeding for severe acute pancreatitis

  1. Amit Kumar Dutta1,*,
  2. Ashish Goel1,
  3. Richard Kirubakaran2,
  4. Ashok Chacko1

Editorial Group: Cochrane Upper Gastrointestinal and Pancreatic Diseases Group

Published Online: 24 JUN 2013

Assessed as up-to-date: 5 JUN 2013

DOI: 10.1002/14651858.CD010582


How to Cite

Dutta AK, Goel A, Kirubakaran R, Chacko A. Nasogastric versus nasojejunal tube feeding for severe acute pancreatitis (Protocol). Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD010582. DOI: 10.1002/14651858.CD010582.

Author Information

  1. 1

    Christian Medical College and Hospital, Department of Gastroenterology, Vellore, Tamil Nadu, India

  2. 2

    Christian Medical College, South Asian Cochrane Network & Centre, Prof. BV Moses & ICMR Advanced Centre for Research & Training in Evidence Informed Health Care, Vellore, Tamil Nadu, India

*Amit Kumar Dutta, Department of Gastroenterology, Christian Medical College and Hospital, Ida Scudder Road, Vellore, Tamil Nadu, 632004, India. akdutta1995@yahoo.co.in. akdutta1995@gmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 24 JUN 2013

SEARCH

 

Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Appendices
  6. Contributions of authors
  7. Declarations of interest
  8. Sources of support
 

Description of the condition

Acute pancreatitis is an acute inflammatory condition of the pancreas caused by a number of different etiological factors, and is seen by clinicians all over the world. The incidence of acute pancreatitis varies from 10/100,000 to 40/100,000 people in different parts of the world, and recent reports suggest that the incidence of this condition is rising (Spanier 2008). It affects men more often than women, and the patients' median age is between 50 and 60 years (Spanier 2008). Alcohol and gall stones account for more than three quarters of the cases. Other etiological factors include drugs, metabolic conditions, post-endoscopic retrograde cholangiopancreatography, autoimmune disorders, trauma, infection, and genetic and anatomical abnormalities. Acute pancreatitis is often a mild self-limiting illness where most patients are managed with intravenous fluids and analgesics. Oral feeds are withheld for a few days during which time the pain settles (Jiang 2007). In about 20% of patients, the disease is severe and has a prolonged course. The mortality rate in these patients is about 20% and increases with the age of the patient (Spanier 2008). Due to ongoing local and systemic inflammation, the catabolic activity in severe acute pancreatitis is high with resultant negative nitrogen balance (Ioannidis 2008). Providing prompt and adequate nutritional support in this group of patients with severe acute pancreatitis is therefore critical. Parenteral nutrition was standard practice, until a Cochrane review showed that enteral nutrition via nasojejunal (NJ) tube was associated with a lower rate of mortality, infection, multiple organ failure and surgical intervention (Al-Omran 2010). Currently, the enteral route is preferred for providing nutrition in severe acute pancreatitis.

 

Description of the intervention

Enteral nutritional support in acute pancreatitis may be provided via NJ tube or nasogastric (NG) tube. The type of nutrition - (semi)elemental or polymeric - does not seem to affect the outcome (Petrov 2009). An elemental/semi-elemental diet consists of amino acids and oligopeptides, whereas a polymeric diet comprises non-hydrolysed proteins, maltodextrins and long-chain triglycerides (Petrov 2009). NJ tube placement during endoscopy is accomplished by passing a guidewire into the jejunum through the working channel of the endoscope, over which the feeding tube is placed. The position of the tube is confirmed using fluoroscopy. The NJ feeding tube can also be placed at bedside by a dietitian or radiologist under fluoroscopic guidance (Cresci 2003). NG tube placement, on the other hand, is a simple bedside procedure and neither requires a specialist for its performance nor entails the use of fluoroscopy.

 

How the intervention might work

Nutritional support needs to be provided early in the course of severe acute pancreatitis (Ioannidis 2008). Apart from providing nourishment, enteral feeding also helps to maintain gut mucosal function (Ioannidis 2008; Zhao 2003). NG tube feeding may enable prompt nutritional support as it avoids the delay associated with performing a specialised procedure (NJ tube placement) (Eatock 2000; Petrov 2008). The cost of an NG tube is generally less than an NJ tube, and since its placement is not restricted by the availability of endoscopy or fluoroscopy facilities, it is widely available.

 

Why it is important to do this review

In severe acute pancreatitis, stress is laid on providing adequate nutrition without causing stimulation of pancreatic tissue. Delivering nutrients in the jejunum avoids pancreatic stimulation and ensures functional rest to the pancreas. Therefore, feeding via NJ tube became the obvious choice. However, placement of an NJ tube requires endoscopy and fluoroscopy facilities which may not be freely available. It has not been established that providing functional rest to the pancreas improves outcomes and so providing nutritional support via NG tube feeding may be equally effective (Ioannidis 2008). Placement of an NG tube is a relatively simple procedure and does not require special equipment. On the other hand, concerns have been raised about the risk of aspiration associated with NG feeds in patients with altered sensorium and hindrance to NG feeds due to gastric outlet narrowing resulting from retroperitoneal inflammation in severe pancreatitis. Hence, it is important to carry out a systematic review comparing the efficacy and risks associated with NG and NJ tube feeding in people with severe acute pancreatitis.

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Appendices
  6. Contributions of authors
  7. Declarations of interest
  8. Sources of support

To assess the effects of nasogastric versus nasojejunal tube feeding for people with severe acute pancreatitis.

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Appendices
  6. Contributions of authors
  7. Declarations of interest
  8. Sources of support
 

Criteria for considering studies for this review

 

Types of studies

Prospective randomised and quasi-randomised clinical trials.

We will classify studies as quasi-randomised trials if the allocation sequence can be predicted but not decided directly by the triallists, e.g. allocation is by alternative dates; medical record number; date of birth;etc. These studies will be considered to have a high risk of selection bias.

 

Types of participants

We will include patients with severe acute pancreatitis. Clinical presentation with upper abdominal pain and elevated serum amylase or lipase levels would be necessary for diagnosing acute pancreatitis. Any of the following methods for assessing severity in acute pancreatitis would be acceptable (UK 2005):

  • Atlanta criteria,
  • Glasgow score 3 or more,
  • Ranson's score > 3,
  • CT severity index score > 2,
  • C-Reactive protein levels > 150 mg/l, or
  • Author's self-defined diagnosis of severe acute pancreatitis

Trials reporting patients with varying severity of pancreatitis will be included if data on patients with severe acute pancreatitis are available.

 

Types of interventions

We will include trials assessing the intervention: placement of nasogastric tube and feeding done through nasogastric tube. The comparison will be placement of nasojejunal tube and feeding done through nasojejunal tube.

 

Types of outcome measures

 

Primary outcomes

The primary outcome measure will be mortality.

 

Secondary outcomes

  1. Length of hospital stay
  2. Organ failure (single or multiple)
  3. Rate of infection (local or systemic)
  4. Success rate of the procedure(tube placed in the desired position).
  5. Complications associated with the procedure - bleeding, perforation, sinusitis, etc.
  6. Complications associated with the feeds - aspiration, diarrhoea, etc.
  7. Days taken to achieve full nutrition requirement - adequate caloric intake, positive nitrogen balance, etc.
  8. Duration of tube feeding
  9. Duration of analgesic requirement after feeding tube placement
  10. Exacerbation of pain
  11. Surgical intervention

 

Search methods for identification of studies

 

Electronic searches

We will search the following databases with the help of the Review Group's Trials Search Coordinator:

  1. Embase 1980 to present (Appendix 2)
  2. Ovid MEDLINE(R) 1946 to present (Appendix 3)
  3. LILACS- Latin American and Caribbean Center on Health Sciences Information (Search engine: iAH v2.6 powered by WWWISIS) (Appendix 4)

There will be no language restriction for search and selection of trials.

For ongoing trials we will search the following databases:

 

Searching other resources

We will screen the reference lists of relevant studies to find additional trials.

We will search the proceedings of major conferences: Digestive Diseases Week, United European Gastroenterology Federation, American Society for Parenteral and Enteral Nutrition, European Society for Clinical Nutrition and Metabolism, and International Association of Pancreatology.

For potentially-relevant studies not published as full papers, we will ask the lead author to provide us with the complete data.

 

Data collection and analysis

 

Selection of studies

The results of the searches will be combined using reference manager software to remove duplicates.The combined results will be screened by two authors (AKD, AG) independently for inclusion in the systematic review and meta-analysis. The reasons for exclusion of potentially-relevant studies will be stated with reason in the "characteristic of excluded studies" table. Where there is insufficient information to include or exclude a study, we will try to access the full text of the trial to make a decision. When multiple reports of the same study is reported we will collate them as a single study. Disagreement would be resolved by discussion with all the authors. We will present the selection process in a PRISMA flowchart (Figure 1).

 FigureFigure 1. Study flow diagram.

 

Data extraction and management

Data will be extracted independently by two review authors (AKD, AG). All extracted data will be cross verified by another author (RK), between two extraction forms, before being entered into Revman 5.1 (RevMan 2011).

We will extract data from all the included trials into a pre-tested data extraction form on the following domains:

  1. General information (Journal title, year of publication, author names and contact information)
  2. Methods (Diagnosis of acute pancreatitis, severity assessment of acute pancreatitis, trial design, random sequence generation, allocation concealment, blinding, follow up)
  3. Participants (Country, age, gender, co-morbidities, nutritional status)
  4. Interventions (Method of NG and NJ tube placement, position of NJ tube in relation to ligament of Treitz, interval from admission to intervention, number of participants in each arm)
  5. Outcomes (Primary and secondary as specified at Types of outcome measures).
  6. Numerical data required for meta-analysis
  7. Additional information (Funding, conflict of interest).

Any disagreement will be resolved by discussion with all the authors. Missing data will be obtained by contacting the corresponding author of the trial.

 

Assessment of risk of bias in included studies

We will use the 'Risk of bias' tool in RevMan 5.1 (RevMan 2011) to assess the quality of included studies, using the guidelines given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We will assess the following domains:

  • Random sequence generation (selection bias).
  • Allocation concealment (selection bias)
  • Blinding of participants and personnel (performance bias)
  • Blinding of outcome assessment (detection bias)
  • Incomplete outcome data (attrition bias)
  • Selective reporting (reporting bias)
  • Other bias

Due to the nature of the intervention, blinding the person performing the procedure or the patient may not be feasible.

We will present risk of bias assessments using the 'Risk of bias graph' and 'Risk of bias summary' figures. The risk of bias graph will be used discussing each domain of Risk of bias in the Results section. The 'Risk of bias summary' will be used when doing GRADE assessments for the summary of findings table.

 

Measures of treatment effect

For the primary outcome (mortality) and other binary outcomes we will report risk ratios with 95% confidence intervals (CI).

For continuous outcomes we will report mean differences with 95% CI.

 

Unit of analysis issues

Individual patients will be the unit of analysis. For the interventions being studied, a cluster or cross-over trial is unlikely.

 

Dealing with missing data

In the case of any missing data, we would contact the trial authors for the required information.. If missing data are not available, we will analyse the data using intention-to-treat (ITT) when we have dichotomous data. We will assume that the missing participant has not had the event of interest. We also intent to test the validity of these assumptions by performing sensitivity analysis assuming one group had the event and another did not, and vice versa.

 

Assessment of heterogeneity

We will assess heterogeneity among the studies by using the Chi2 test with the alpha level at 10% (Higgins 2002) and quantify it by the Higgins I² statistic (Higgins 2003). We will consider that I² > 50% denotes significant heterogeneity.

In the case of I² > 80% (substantial heterogeneity), we will not perform meta-analysis but will present the results using forest plots without pooled estimates.

 

Assessment of reporting biases

We will create a funnel plot to assess for publication bias if an adequate number of trials is available.

 

Data synthesis

We will use Review Manager 5.1 (RevMan 2011) for data analysis. Treatment effects will be pooled using the Mantel-Haenszel method for dichotomous data which would give the risk ratio with 95% CIs. Continuous data will be pooled using the inverse variance method to obtain the mean difference with 95% CI. We will use the fixed-effect model for the analysis (Higgins 2011).

 

Subgroup analysis and investigation of heterogeneity

We intend to perform the following subgroup analyses to explore the cause of any heterogeneity:

  • Low quality trials versus high quality trials - If we find all these following domains random sequence generation, allocation concealment and selective outcome reporting with low risk of bias we will classify as high quality trials.
  • Trials with early (≤ 48 hours of admission) versus delayed (> 48 hours after admission) enteral nutrition
  • Randomised versus quasi randomised trials
  • Trials with (semi)elemental versus trials with polymeric diet
  • Trials with different scoring systems of severe pancreatitis

 

Sensitivity analysis

We will perform a sensitivity analysis to explore the influence of the following factors on effect sizes.

  1. Restricing the analysis by excluding the quasi-randomised studies.
  2. Restricting the analysis by excluding the trials using Ranson's and Glasgow score for severity assessment.

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Appendices
  6. Contributions of authors
  7. Declarations of interest
  8. Sources of support
 

Appendix 1. CENTRAL search strategy

  1. (acute adj3 pancrea*).mp. [mp=protocol supplementary concept, rare disease supplementary concept, title, original title, abstract, name of substance word, subject heading word, unique identifier]
  2. (necro* adj3 pancrea*).mp. [mp=protocol supplementary concept, rare disease supplementary concept, title, original title, abstract, name of substance word, subject heading word, unique identifier]
  3. (inflam* adj3 pancrea$).mp. [mp=protocol supplementary concept, rare disease supplementary concept, title, original title, abstract, name of substance word, subject heading word, unique identifier]
  4. (edema* adj2 pancrea*).mp.
  5. or/1-4
  6. ((Nasogastric or nasoenteral or nasojejunal or enteral) adj2 (intubat* or tube* or feed*)).mp.
  7. (post-pyloric feeding or postpyloric feeding).mp. [mp=protocol supplementary concept, rare disease supplementary concept, title, original title, abstract, name of substance word, subject heading word, unique identifier]
  8. Enteral Nutrition/
  9. Intubation, Gastrointestinal/
  10. or/6-9
  11. 5 and 10

 

Appendix 2. EMBASE search strategy

  1. random:.tw. or placebo:.mp. or double-blind:.tw.
  2. (acute adj3 pancrea*).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
  3. (necro* adj3 pancrea*).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
  4. (inflam* adj3 pancrea$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
  5. or/2-4
  6. digestive tract intubation/
  7. enteric feeding/
  8. nose feeding/
  9. tube feeding/
  10. ((Nasogastric or nasoenteral or nasojejunal or enteral) adj2 (intubat* or tube* or feed*)).mp.
  11. (post-pyloric feeding or postpyloric feeding).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
  12. or/6-11
  13. 1 and 5 and 12

 

Appendix 3. MEDLINE search strategy

  1. randomized controlled trial.pt.
  2. controlled clinical trial.pt.
  3. randomized.ab.
  4. placebo.ab.
  5. drug therapy.fs.
  6. randomly.ab.
  7. trial.ab.
  8. groups.ab.
  9. or/1-8
  10. exp animals/ not humans.sh.
  11. 9 not 10
  12. (acute adj3 pancrea*).mp. [mp=protocol supplementary concept, rare disease supplementary concept, title, original title, abstract, name of substance word, subject heading word, unique identifier]
  13. (necro* adj3 pancrea*).mp. [mp=protocol supplementary concept, rare disease supplementary concept, title, original title, abstract, name of substance word, subject heading word, unique identifier]
  14. (inflam* adj3 pancrea$).mp. [mp=protocol supplementary concept, rare disease supplementary concept, title, original title, abstract, name of substance word, subject heading word, unique identifier]
  15. (edema* adj2 pancrea*).mp.
  16. or/12-15
  17. ((Nasogastric or nasoenteral or nasojejunal or enteral) adj2 (intubat* or tube* or feed*)).mp.
  18. (post-pyloric feeding or postpyloric feeding).mp. [mp=protocol supplementary concept, rare disease supplementary concept, title, original title, abstract, name of substance word, subject heading word, unique identifier]
  19. Enteral Nutrition/
  20. Intubation, Gastrointestinal/
  21. or/17-20
  22. 11 and 16 and 21

 

Appendix 4. LILACS search strategy

((inflam$ or edema$) and pancrea$) and ((Nasogastric or nasoenteral or nasojejunal or enteral) and (intubat$ or tube$ or feed$)) [Words] or C06.689.750.650 AND (E05.497.412 OR E02.421.360) [DeCS Category]

(DeCS: a trilingual coding which encompasses English, Spanish and Portuguese vocabulary)

C06.689.750.650= Acute Necrotizing Pancreatitis

E05.497.412= Intubation, Nasogastric

E02.421.360= Enteral Nutrition

 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Appendices
  6. Contributions of authors
  7. Declarations of interest
  8. Sources of support

Conceiving the review: AKD

Designing the review: AKD, AG, RK

Coordinating the review: AKD

Writing the protocol: AKD, AG, RK, AC

Providing general advice on the protocol: AC, AG

 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Appendices
  6. Contributions of authors
  7. Declarations of interest
  8. Sources of support

None of the authors have any conflicts of interest.

 

Sources of support

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Appendices
  6. Contributions of authors
  7. Declarations of interest
  8. Sources of support
 

Internal sources

  • Christian Medical College, India.

 

External sources

  • Department for International Development (DFID), UK.
    Funding for the Prof. BV Moses Centre for Advanced Research in Evidence-Informed Healthcare; Salary support for Richard Kirubakaran through Effective Healthcare Research Consortium.

References

Additional references

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
  10. Additional references
Al-Omran 2010
Cresci 2003
Eatock 2000
  • Eatock FC, Brombacher GD, Steven A, Imrie CW, McKay CJ, Carter R. Nasogastric feeding in severe acute pancreatitis may be practical and safe. International Journal of Pancreatology 2000;28(1):23-9.
Higgins 2002
Higgins 2003
Higgins 2011
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
Ioannidis 2008
  • Ioannidis O, Lavrentieva A, Botsios D. Nutrition support in acute pancreatitis. Journal of the Pancreas 2008;9(4):375-90.
Jiang 2007
  • Jiang K, Chen XZ, Xia Q, Tang WF, Wang L. Early nasogastric enteral nutrition for severe acute pancreatitis: a systematic review. World Journal of Gastroenterology 2007;13(39):5253-60.
Petrov 2008
  • Petrov MS, Correia MI, Windsor JA. Nasogastric tube feeding in predicted severe acute pancreatitis: A systematic review of the literature to determine safety and tolerance. Journal of the Pancreas 2008;9(4):440-8.
Petrov 2009
RevMan 2011
  • The Nordic Cochrane Centre,The Cochrane Collaboration. Review Manager (RevMan). 5.1. Copenhagen: The Nordic Cochrane Centre,The Cochrane Collaboration, 2011.
Spanier 2008
  • Spanier BW, Dijkgraaf MG, Bruno MJ. Epidemiology, aetiology and outcome of acute and chronic pancreatitis: an update. Best Practice and Research. Clinical Gastroenterology 2008;22(1):45-63. [PUBMED: 18206812]
UK 2005
  • UK Working Party on Acute Pancreatitis. UK guidelines for the management of acute pancreatitis. Gut 2005;54(Suppl 3):iii1-9.
Zhao 2003
  • Zhao G, Wang CY, Wang F, Xiong JX. Clinical study on nutrition support in patients with severe acute pancreatitis. World Journal of Gastroenterology 2003;9(9):2105-8.