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Closure of POPF After PancreaticoduodenectomyNCT01755260

Route of Nutritional Support for Pancreatic Fistula

A study testing Jejunostomy tube feeding in people with Closure of POPF After Pancreaticoduodenectomy, run by National Taiwan University Hospital at 2 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to compare the closure rate of pancreatic fistula (PF) after pancreaticoduodenectomy (PD) under various types of nutrition. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Jejunostomy tube feeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesTaiwan
Study dates
Sep 2013to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged more than 20 years old and develop pancreatic fistula after pancreatectomy

Who cannot join

  • major co-morbidities
  • severe pancreatic fistula needing intervention

Trial locations and contacts

2 sites in 1 country.

Jin-Ming Wu, MD contact

kptkptkpt@yahoo.com.tw

Taiwan2 sites, 2 recruiting
  • National Taiwan University Hospital

    Taipei, Taiwan, 10002

    Yu-Wen Tien, ywtien5106@ntu.edu.tw

    Yu-Wen Tien

    Recruiting
  • National Taiwan University Hospital

    Taipei, 10002

    Yu-Wen Tien, ywtien5106@ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Nutrition Through Oral Intake Versus Feeding Jejunostomy in the Conservative Treatment of Pancreatic Fistula After Pancreaticoduodenectomy: a Prospective Multicenter Randomized Clinical Trial

The aim of this study is to compare the closure rate of pancreatic fistula (PF) after pancreaticoduodenectomy (PD) under various types of nutrition.

Read the detailed description

Postoperative pancreatic fistula (POPF) is the most detrimental complication of pancreatic surgery due to the potential life-threatening consequences of fluid and electrolyte imbalance, nutritional depletion, sepsis, and local complications, such as abdominal abscess and hemorrhage.1 Incidence rates vary considerably from 0 to 24% due to the differences in definitions with an overall rate of 12.9% in a recent series.1,2 Several risk factors have been identified, mostly a soft parenchyma and a small main pancreatic duct diameter; however, numerous attempts to reduce fistula rates with either pharmacological prophylaxis or application of some special surgical techniques failed to improve postoperative outcomes. The primary therapy for POPF today includes adequate drainage of pancreatic exocrine secretions and conservative treatment, consisting of nutritional support and correction of electrolyte disturbances and fistula-related complications. 3-5 These recommendations are based on previous observations suggesting that up to 70% of cases eventually resolve spontaneously.3,5,6 However, the patient's discomfort, the need for follow-up visits and the substantial costs of prolonged therapy initiated various attempts to accelerate closure rates. Several measures have been proposed, including fibrin glues, endoscopic interventions, or the use of somatostatin analogues to inhibit pancreatic exocrine secretion. Nevertheless, these methods lack any convincing evidence that the proposed regimens may be clinically effective.4,7,8 Nutritional support is the key element of conservative therapy in patients with POPF, as most of them are in a catabolic state and attempts to accelerate fistula closure usually involve prolonged fasting. However, the decision between total parenteral nutrition (TPN) and enteral nutrition is essentially arbitrary because the effects of both diets on closure rates of postoperative pancreatic fistula have not been compared in a randomized clinical trial.3,9 Experiments with healthy individuals have demonstrated that intravenous feeding does not stimulate pancreatic secretion, and thus is a reasonable solution when prolonged nutritional support is needed without increasing the exocrine pancreatic function.10 However, previous research has suggested that long-term TPN leads to negative functional and morphological changes, not only within the gastrointestinal mucosa but also atrophy and dysfunction of the exocrine pancreas.11 Therefore, enteral feeding beyond the ligament of Treitz is commonly preferred over the intravenous route due to lower costs and the potential advantage of avoiding infectious and metabolic complications related to the parenteral route. This hypothesis was substantiated in several clinical trials demonstrating that enteral nutrition via a nasojejunal tube can be safely used in patients with various disorders, including acute pancreatitis and postoperative pancreatic fistula. 12-15Some of these reports suggested that the enteral route offers major advantages over TPN in terms of faster recovery and lower rates of disease- and nutrition-related complications.16 However, data concerning chronic pancreatic conditions are limited.17 It is well established that the duodenum is the major site of pancreatic secretion stimulation. Cholecystokinin (CCK) and secretin released in the duodenum and enteropancreatic reflexes mediated by vago-vagal cholinergic pathways are responsible for the majority of pancreatic exocrine secretion.18Without raising CCK levels, the enteropancreatic reflex can be activated with a corresponding increase in pancreatic enzyme secretion, by distention or administration of hyperosmolar solutions in the duodenum. Pancreatic polypeptide (PP) secretion is also under cholinergic control and thus may be a modulator of pancreatic secretion stimulated by the vagal cholinergic pathway.19 It has also been shown that intraileal or colonic perfusion of nutrients decreases pancreatic exocrine secretion, possibly mediated through the ileal-brake gut peptides, namely peptide YY (PYY) and glucagon-like peptide-1 (GLP-1). 20-22 Enteral feeding via a nasojejunal feeding tube necessitates endoscopic placement which could be dangerous in immediately operated patients with gastrojejunostomy and might cause tube-related discomfort to patients. Anatomically, pancreaticoduodenectomy will include removal of duodenum and proximal 10 ~ 15 cm jejunum (Figure 1). In addition, another 30~40 cm-long jejunum will be brought up for pancreatic and biliary anastomosis (figure 2). Therefore, the last enteral anastomosis (gastrojejunostomy or duodenojejunostomy) will be made at site of 40~50 cm distal to Treitz ligament which is far more distal than site of nasojejunal tube used in patients with acute pancreatitis. Therefore, we hypothesize that oral feeding in patients operated with PD will not stimulate but inhibit pancreatic secretion and hasten closure of pancreatic fistula. To test this hypothesis, we propose a prospective randomized trial to test the effect of various nutrition methods on healing of PF after PD. Patients will be randomized into 2 groups (A and B). Eligible patients will be randomized in a 1:1 ratio to receive oral feeding nutrition, or TPN as a standard therapy of POPF. The primary end points will be closure rate of PF. Secondary end points will include length and cost of hospital stay after operation.

pancreatic exocrine secretion. Nevertheless, these methods lack any convincing evidence that the proposed regimens may be clinically effective.

Nutritional support is the key element of conservative therapy in patients with POPF, as most of them are in a catabolic state and attempts to accelerate fistula closure usually involve prolonged fasting. However, the decision between total parenteral nutrition (TPN) and enteral nutrition is essentially arbitrary because the effects of both diets on closure rates of postoperative pancreatic fistula have not been compared in a randomized clinical trial. Experiments with healthy individuals have demonstrated that intravenous feeding does not stimulate pancreatic secretion, and thus is a reasonable solution when prolonged nutritional support is needed without increasing the exocrine pancreatic function. However, previous research has suggested that long-term TPN leads to negative functional and morphological changes, not only within the gastrointestinal mucosa but also atrophy and dysfunction of the exocrine pancreas. Therefore, enteral feeding beyond the ligament of Treitz is commonly preferred over the intravenous route due to lower costs and the potential advantage of avoiding infectious and metabolic complications related to the parenteral route. This hypothesis was substantiated in several clinical trials demonstrating that enteral nutrition via a nasojejunal tube can be safely used in patients with various disorders, including acute pancreatitis and postoperative pancreatic fistula. Some of these reports suggested that the enteral route offers major advantages over TPN in terms of faster recovery and lower rates of disease- and nutrition-related complications. However, data concerning chronic pancreatic conditions are limited.

It is well established that the duodenum is the major site of pancreatic secretion stimulation. Cholecystokinin (CCK) and secretin released in the duodenum and enteropancreatic reflexes mediated by vago-vagal cholinergic pathways are responsible for the majority of pancreatic exocrine secretion. Without raising CCK levels, the enteropancreatic reflex can be activated with a corresponding increase in pancreatic enzyme secretion, by distention or administration of hyperosmolar solutions in the duodenum. Pancreatic polypeptide (PP) secretion is also under cholinergic control and thus may be a modulator of pancreatic secretion stimulated by the vagal cholinergic pathway. It has also been shown that intraileal or colonic perfusion of nutrients decreases pancreatic exocrine secretion, possibly mediated through the ileal-brake gut peptides, namely peptide YY (PYY) and glucagon-like peptide-1 (GLP-1).

Enteral feeding via a nasojejunal feeding tube necessitates endoscopic placement which could be dangerous in immediately operated patients with gastrojejunostomy and might cause tube-related discomfort to patients. Anatomically, pancreaticoduodenectomy will include removal of duodenum and proximal 10 ~ 15 cm jejunum (Figure 1). In addition, another 30~40 cm-long jejunum will be brought up for pancreatic and biliary anastomosis (figure 2). Therefore, the last enteral anastomosis (gastrojejunostomy or duodenojejunostomy) will be made at site of 40~50 cm distal to Treitz ligament which is far more distal than site of nasojejunal tube used in patients with acute pancreatitis. Therefore, we hypothesize that oral feeding in patients operated with PD will not stimulate but inhibit pancreatic secretion and hasten closure of pancreatic fistula. To test this hypothesis, we propose a prospective randomized trial to test the effect of various nutrition methods on healing of PF after PD. Patients will be randomized into 2 groups (A and B). Eligible patients will be randomized in a 1:1 ratio to receive oral feeding nutrition, or TPN as a standard therapy of POPF. The primary end points will be closure rate of PF. Secondary end points will include length and cost of hospital stay after operation.

Being tested
Jejunostomy tube feeding
Keywords
POPF, pancreaticoduodenectomy, enteral nutrition, parenteral nutrition
Medical subject headings
Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jejunostomy tube feedingOther

    The patients at this arm receive the nutritional support through the feeding jejunostomy tube; they can only eat or sip water through mouth

Study groups in NCT01755260
Study groupRoleWhat they receive
oral intakeNo interventionThe patients at this arm were allowed to take food through mouth
Receives: Other: Jejunostomy tube feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Closure of pancreatic fistula within 30 days

    Measured: 30 days

Secondary outcomes (1)
  1. Cost of therapy

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2012 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01755260
Sponsor's protocol ID
201202048RIB
Status last verified
Oct 2016
First submitted
18 Dec 2012
Last updated
5 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Wu JM, Kuo TC, Chen HA, Wu CH, Lai SR, Yang CY, Hsu SY, Ho TW, Liao WC, Tien YW. Randomized trial of oral versus enteral feeding for patients with postoperative pancreatic fistula after pancreatoduodenectomy. Br J Surg. 2019 Feb;106(3):190-198. doi: 10.1002/bjs.11087.

    PubMed 30724356

Questions about this trial

What is this clinical trial studying?

A study testing Jejunostomy tube feeding in people with Closure of POPF After Pancreaticoduodenectomy, run by National Taiwan University Hospital at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jin-Ming Wu, MD (kptkptkpt@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Closure of pancreatic fistula within 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01755260, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.

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