Is Viokace with bicarb tabs still the recommended course of action to declog a feeding tube?

Comment by InpharmD Researcher

While the overall evidence regarding the most effective method for declogging enteral feeding tubes is limited, the available literature supports the use of Viokase with sodium bicarbonate as a reasonable treatment option. The American College of Gastroenterology guidelines recommend warm water instillation as the initial management strategy, followed by the use of a nonenteric-coated pancreatic enzyme such as Viokase combined with sodium bicarbonate if the initial attempt with warm water is unsuccessful. Furthermore, a limited number of studies suggest that Viokase may be more effective in clearing enteral tube occlusions compared to other pancreatic enzyme preparations (e.g., Creon).

Background

A 2016 guideline presented evidence-based recommendations for nutrition therapy in hospitalized adults, including the management of complications associated with enteral feeding. Specifically, for the management of a clogged enteral tube, the guideline recommended an initial attempt to declog the tube by instilling warm water via syringe with agitated back-and-forth motion. In cases where this is unsuccessful, the guideline suggested crushing a nonenteric-coated pancreatic enzyme tablet (e.g., Viokase) and a 650 mg sodium bicarbonate tablet together in warm water. This mixture should then be instilled into the g-tube using a similar agitated motion with a syringe. The guideline further noted that the use of a carbonated soft drink represents an acceptable alternative approach. [1]

A 2011 review described appropriate methods for dissolving pancreatic enzyme preparations for administration via enteral tube feed. Recommendations for preparation solely focused on use of enteric-coated microspheres. When pancreatic enzymes are to be given into a gastrically placed enteral feeding tube, the microspheres should be left whole so that the enteric coating can protect the enzyme activity from gastric acid. Giving the microspheres as a slurry in water, however, allows them to clump in the feeding tube, causing a blockage. Clumping may be avoided using a mildly thickened or “nectar”-consistency fruit juice as it can help maintain the enteric coating and keep the microspheres suspended. Adequate flushing with water, before and after administration, is necessary to prevent interaction with the acidic juice and the feed formula. Of note, Viokase is only available as a non-enteric coated tablet formulation. Thus, it is unknown if these same preparation/administration techniques can be utilized for Viokase for enzyme supplementation. [2]

Additionally, a 2015 study evaluated the administration of pancreatic enzyme preparations in bicarbonate solution via enteral feeding tubes. Four delayed-release pancrelipase products were evaluated (Creon, Pancreaze, Ultresa, and Zenpep). Each of these formulations are available in capsules that contain multiple enteric coated granules. The intact contents of each dose of pancrelipase product was added to 20 mL of 8.4% sodium bicarbonate injection in a 50-mL polypropylene conical tube. Only one dose of Creon completely dissolved in sodium bicarbonate at 30 minutes (24,000 lipase units). No doses of Pancreaze and only the lowest dose of Ultresa (23,000 lipase units) were completely dissolved at 30 minutes. Zenpep doses of 20,000 and 40,000 lipase units were completely dissolved in 30 minutes. The baseline pH of the solvent decreased slightly once pancrelipase was added, but returned towards baseline after granule dissolution. Relative particle count increased over time and with increasing doses. Osmolality varied across pancrelipase products and times. As this study was primarily a stability study, it did not evaluate the effects on the patient following enteral tube administration. Results of this study are likely not generalizable to Viokace dissolved in sodium bicarbonate, as Viokace is in the form of a tablet, and the preparations evaluated within this study are in the form of delayed-release enteric coated granules. [3]

Viokace is considered the best choice of pancrelipase to use for clogged feeding tubes, as other preparations (i.e., Creon, Zenpep) are enteric-coated. To unclog with Viokace, the authors recommend crushing one tablet and dissolve with one non-enteric-coated tablet of sodium bicarbonate (324 mg) or ⅛ teaspoon of baking soda in 5 mL of water. The sodium bicarbonate creates an alkaline pH for clog dissolving. Allow this enzyme solution to soak in the tube before flushing with 30-60 mL of water. [4]

The use of Viokase tablets combined with sodium bicarbonate was a previously effective protocol for declogging feeding tubes, showing a high efficacy rate of 71.9% in a clinical trial. This method involved crushing a Viokase tablet with a sodium bicarbonate tablet, dissolving them in warm water, and instilling the solution into occluded tubes. The effectiveness increased to a remarkable 95.8% when excluding clogs unrelated to the feeding formula, such as mechanical issues. However, Viokase was removed from the US market in 2010 due to its status as an unapproved drug, leading to changes in clinical practice. Subsequent to the removal of Viokase, the protocol was adapted to use Creon delayed-release capsules, despite limited published efficacy data. Creon, which contains pancreatic enzymes in enteric-coated beads designed for delayed release, was combined with a higher dose of sodium bicarbonate in attempts to clear feeding tube obstructions. However, in a 2014 retrospective study, the modified protocol using Creon demonstrated significantly lower success, with only 48.2% of tubes being cleared. Despite its efficacy, the clearance rate observed was substantially lower than the 95.8% success rate previously documented using an alkalinized Viokase-based protocol. This is notably less effective compared to the previous Viokase-based method. [5]

A 2021 retrospective, quality assurance study compared a Viokace-based alkalinized pancreatic enzyme protocol to a Creon-based alkalinized solution using historical data (Table 1). The Viokace protocol successfully cleared 176 of the 277 (63.5%) occluded enteral feeding tubes, which appeared to have a significantly higher success rate than the previous protocol using Creon delayed-release pancreatic enzyme capsules (p= 0.0056); however, interpretations from indirect comparison must be made cautiously. Therefore, while the Viokase and bicarbonate combination was once recommended, the change to Creon has not retained the same level of effectiveness, highlighting a gap in highly effective options for declogging feeding tubes. [5], [6]

References:

[1] McClave SA, DiBaise JK, Mullin GE, Martindale RG. ACG Clinical Guideline: Nutrition Therapy in the Adult Hospitalized Patient. Am J Gastroenterol. 2016;111(3):315-335. doi:10.1038/ajg.2016.28
[2] Ferrie S, Graham C, Hoyle M. Pancreatic enzyme supplementation for patients receiving enteral feeds. Nutr Clin Pract. 2011;26(3):349-351. doi:10.1177/0884533611405537
[3] Boullata AM, Boullata JI. Pancreatic enzymes prepared in bicarbonate solution for administration through enteral feeding tubes. Am J Health Syst Pharm. 2015;72(14):1210-1214. doi:10.2146/ajhp140611
[4] Fisher C, Balock B. Clogged Feeding Tubes: A Clinician’s Thorn. Practical Gastro. 2014;38(3):16-22.
[5] Stumpf JL, Kurian RM, Vuong J, Dang K, Kraft MD. Efficacy of a Creon delayed-release pancreatic enzyme protocol for clearing occluded enteral feeding tubes. Ann Pharmacother. 2014;48(4):483-487. doi:10.1177/1060028013515435
[6] Kurish HP, Gabriel JM, Bruck CL, Stumpf JL. Efficacy of a Viokace Pancreatic Enzyme Protocol for Clearing Occluded Enteral Feeding Tubes: A Quality Assurance Evaluation [published online ahead of print, 2021 Aug 2]. J Pharm Pract. 2021;89719002

Relevant Prescribing Information

VIOKACE should be taken during meals or snacks, with sufficient fluid. Tablets should be swallowed whole. Do not crush or chew tablets. Care should be taken to ensure that no drug is retained in the mouth to avoid mucosal irritation. Since VIOKACE is not enteric-coated, it should be taken in combination with a proton pump inhibitor. [7]

References:

[7] Viokace (pancrelipase). Prescribing information. Aimmune Therapeutics, Inc.; 2024.

Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

Is viokace with bicarb tabs still the recommended course of action to declog a feeding tube?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→



Please see Tables 1-2 for your response.


 

Efficacy of a Viokace Pancreatic Enzyme Protocol for Clearing Occluded Enteral Feeding Tubes: A Quality Assurance Evaluation

Design

Retrospective, cohort quality assurance study

N= 205

Objective

To evaluate the effectiveness of an alkalinized solution of the new formulation of Viokace® in clearing enteral feeding tube obstructions according to updated procedures

Study Groups

All patients (N= 205)

Occluded tubes (n= 277)

Inclusion Criteria

Adult and pediatric patients admitted to the study institution or seen in the emergency department, prescribed an alkalinized solution of clearing occluded enteral feeding tubes 

Exclusion Criteria

Did not receive Viokace as prescribed or received Viokace for any indication other than clearance of occluded enteral feeding tubes, cases involving physical obstructions of the tube (e.g., kinked tubes)

Methods

All pertinent data were collected from electronic medal records. If flushing the tube with warm sterile water and clamping for 5 minutes did not clear the occlusions, the institutional protocol used for clearing occluded enteral tubes was as follows:

1. Thoroughly crush and dissolve one Viokace (10,440 lipase units/39,150 protease units/39,150 amylase units) pancreatic enzyme tablet and one sodium bicarbonate 325 mg tablet in 5 mL warm sterile water.

2. Instill the pancreatic enzyme/bicarbonate solution using light pressure and clamp the enteral feeding tube for 5–15 minutes.

3. Use warm sterile water to aspirate or flush the tube. A light “back and forth” motion with the syringe plunger is suggested in order to dislodge the clog.

4. The procedure may be repeated if needed.

The tube clearance protocol was deemed ineffective if documented as such in the medical record or if the enteral feeding tube was removed or replaced following administration of the pancreatic enzyme solution.

Duration

Hospital admission or seen in the emergency department: September 1, 2014 to August 31, 2015

Outcome Measures

Percentage of occluded tubes successfully cleared

Baseline Characteristics

 

All patients (N= 205)

Median age, years (range)

48 (1 day to 94 years) 

Female

44.4% 

Enteral feeding tube type

Dobhoff

Nasogastric

Nasojejunal

Jejunostomy

Gastrostomy

Gastrojejunostomy



43.6%

14.8%

11.6%

11.2%

9.7%

7.9%

Specific causes of obstruction were not documented frequently. The most common causes included enteral nutrition (17 cases) and medications (13 cases).

Results

Endpoint

Occluded tubes (n= 277)

Successful clearance of occluded tubes

176 (63.5%) 

In 25 of the 277 cases, the protocol was repeated after the initial Viokace instillation was ineffective, resulting in the clearance of 10 occlusions. In 6 cases, the Viokace protocol was administered a third time, successfully clearing 5 additional enteral feeding tubes. 

The efficacy of the protocol was not affected by patient age (adult vs. pediatric, p= 0.0635) or type of enteral feeding tube (p= 0.215).

Adverse Events

No adverse effects were attributed to Viokace administration.

Study Author Conclusions

According to this retrospective evaluation, an alkalinized Viokace pancreatic enzyme protocol was effective in clearing 63.5% of occluded enteral feeding tubes. This significantly higher success rate than previously documented with a Creon-based protocol supports the change in pancreatic enzyme formulations in the institutional protocol.

InpharmD Researcher Critique

It was reported that this protocol was significantly more effective at clearing occluded enteral feeding tubes than the protocol set forth in the study by Stumpf et al. (p= 0.0056). Despite this, there was most likely variability in the preparation and administration of the pancreatic enzyme solution, which may have confounded results.



References:

Kurish HP, Gabriel JM, Bruck CL, Stumpf JL. Efficacy of a Viokace Pancreatic Enzyme Protocol for Clearing Occluded Enteral Feeding Tubes: A Quality Assurance Evaluation [published online ahead of print, 2021 Aug 2]. J Pharm Pract. 2021;8971900211036590. doi:10.1177/08971900211036590

 

Unclogging Feeding Tubes with Pancreatic Enzyme

Design

Prospective, single-arm study

N= 90 patients followed; 32 patients with tube occlusions; 44 declogging attempts

Objective

To evaluate possible causes of tube occlusion and to assess the efficacy of an activated pancreatic enzyme solution to clear obstructed feeding tubes

Study Groups

All patients (N= 90 patients followed; 32 patients with tube occlusions)

Inclusion Criteria

Patients receiving enteral feeding through a Dobbhoff tube

Exclusion Criteria

N/A

Methods

Patients receiving enteral feeding through a Dobbhoff tube were followed daily over an 8-month period to monitor for tube clogging. Declogging of obstructed feeding tubes was attempted within 24 hours or as soon as the nutrition support team was notified. Declogging was done by inserting a Drum cartridge catheter (Abbott Laboratories, North Chicago, IL) into the occluded feeding tube to inject the declogging solution. Water was injected first, and the feeding tube was clamped for five minutes. If the tube failed to unclog, a pancreatic enzyme solution was injected near the formula clot to displace any liquid formula close to the obstruction site and unclog the tube. The feeding tube was also clamped for five minutes after injection of the pancreatic solution. Afterward, a 50 mL syringe was attached to the feeding tube using an adapter and flushed gently with tap water to regain patency. Patients were followed until the removal of their feeding tubes, and inspection of the feeding tubes revealed no cases of tube perforation.

The pancreatic enzyme solution was made by crushing one tablet of Viokase and one tablet of sodium bicarbonate 324 mg and dissolving the powder in 5 mL of warm water prior to injection into the catheter. 

Duration

Enrolment: 8 months

Follow-up: until removal of feeding tube

Outcome Measures

Successful declogging

Baseline Characteristics

 

All patients (N= 90 patients followed)

Age, years

61 ± 2 

Female

50%

Feeding tube occlusion

35%

Occluded tube location

Stomach

Duodenum

 

78%

12%   

Results

Endpoint

Water

Pancreatic enzyme

Tube declogging*

Success

Failure

 

12 (27%)

32 (73%)

 

23 (72%)

9 (28%)

p< 0.01 (Fisher's exact test).

Thirty-two patients with small-bore feeding tubes experienced 60 episodes of tube occlusion, and the nutrition support team was notified for declogging in 44 cases.

The reason for failure to clear the occluded tubes with pancreatic enzyme solution was determined in seven cases and included tablet impaction (three cases), knotted feeding tube (two cases), tomato seed occluding the feeding port (one case), and formula clot in 2/3 length of the tube for 24 hours (one case). 

Adverse Events

Not disclosed

Study Author Conclusions

Activated pancreatic enzyme solution, when applied close to the clotted formula, has a 96% success rate in clearing the obstruction in cases where water failed.

InpharmD Researcher Critique

The study demonstrated the successful declogging of enteral feeding tubes using a Viokase solution. 



References:

Marcuard SP, Stegall KS. Unclogging feeding tubes with pancreatic enzyme. JPEN J Parenter Enteral Nutr. 1990;14(2):198-200. doi:10.1177/0148607190014002198