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.
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
- Conditions the study is for
- Closure of POPF After Pancreaticoduodenectomy
- 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
Taiwan2 sites, 2 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| oral intake | No intervention | The 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.
Closure of pancreatic fistula within 30 days
Measured: 30 days
Secondary outcomes (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.
- First posted24 Dec 2012 (estimated)
- Study startSep 2013
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Closure of POPF After PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Wen Tien, Principal investigator, National Taiwan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Through Oral Intake Versus Feeding Jejunostomy in the Conservative Treatment of Pancreatic Fistula After Pancreaticoduodenectomy: a Prospective Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01755260
- Acronym / sponsor ID
- 201202048RIB
- Keywords
- POPF, pancreaticoduodenectomy, enteral nutrition, parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the closure rate of pancreatic fistula (PF) after pancreaticoduodenectomy (PD) under various types of nutrition.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral intake | No intervention | Other: Jejunostomy tube feedingThe patients at this arm were allowed to take food through mouth |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged more than 20 years old and develop pancreatic fistula after pancreatectomy
Key exclusion criteria (2 listed)
- major co-morbidities
- severe pancreatic fistula needing intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jejunostomy tube feedingThe patients at this arm receive the nutritional support through the feeding jejunostomy tube; they can only eat or sip water through mouth | Other | oral intake |
Primary outcome
Closure of pancreatic fistula within 30 days
Time frame: 30 days
1 secondary outcome
Cost of therapy
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Derived from this study: PubMed 30724356Wu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Ming Wu, MD contact
Yu-Wen Tien principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
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.