Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-10-01
Study Completion Date
2019-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Acute pancreatitis is a frequently devastating pancreatic inflammatory process that results in extensive morbidity, mortality, and hospitalization costs. The incidence of acute pancreatitis has been increasing over the last decade with an overall mortality rate of 5%, although it may be as high as 30% in the most severe cases. It was the most common inpatient gastrointestinal diagnosis in 2009, totaling over 270,000 hospitalizations with estimated "inpatient costs" of over 2.5 billion dollars in the United States. However, despite the significant impact to both patients and the healthcare system, there is no proven pharmacologic therapy that improves important clinical outcomes in acute pancreatitis. The release of bicarbonate rich fluid into the pancreatic duct from the ductal cells is an important mechanism to protect against pancreatitis by two distinct mechanisms:
1. "Flushing" activated enzymes out of the pancreas and into the duodenum thereby preventing accumulation of activated enzymes within the pancreatic acinus
2. Directly alkalinizing the acinar cells, which limits intra-acinar cell damage by improving trafficking of inappropriately activated intra-acinar enzymes along the apical membrane.
In addition to standard care, patients will be divided into 4 cohorts. Cohorts 1,2 and 3 will be treated with different doses of intravenous synthetic human secretin. Cohort X will not receive human secretin, but all datapoints and specimens will be collected. The patient cohorts will be entered into the study as follows: Cohort X; Cohort 1; Cohort 2; Cohort 3. 5 patients in each cohort will be evaluated at each center (for a total of n=10 at both centers for each cohort). Dosing will start within 24 hours of hospitalization with no further synthetic human secretin administration beyond Day 3. Patients will continue to be followed for 7 days or until discharge, whichever comes first. Any data recorded to that point would be included in an intent-to-treat analysis. The primary objective is to perform a Phase II Pilot Study to explore the efficacy of intravenous synthetic human secretin as a pharmacologic adjunct to modulate the severity of human acute (non-obstructive) pancreatitis.
1. "Flushing" activated enzymes out of the pancreas and into the duodenum thereby preventing accumulation of activated enzymes within the pancreatic acinus
2. Directly alkalinizing the acinar cells, which limits intra-acinar cell damage by improving trafficking of inappropriately activated intra-acinar enzymes along the apical membrane.
In addition to standard care, patients will be divided into 4 cohorts. Cohorts 1,2 and 3 will be treated with different doses of intravenous synthetic human secretin. Cohort X will not receive human secretin, but all datapoints and specimens will be collected. The patient cohorts will be entered into the study as follows: Cohort X; Cohort 1; Cohort 2; Cohort 3. 5 patients in each cohort will be evaluated at each center (for a total of n=10 at both centers for each cohort). Dosing will start within 24 hours of hospitalization with no further synthetic human secretin administration beyond Day 3. Patients will continue to be followed for 7 days or until discharge, whichever comes first. Any data recorded to that point would be included in an intent-to-treat analysis. The primary objective is to perform a Phase II Pilot Study to explore the efficacy of intravenous synthetic human secretin as a pharmacologic adjunct to modulate the severity of human acute (non-obstructive) pancreatitis.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Secretin Infusion for Pain Due to Chronic Pancreatitis
NCT01265875
Chronic Pancreatitis
COMPLETED
PHASE1/PHASE2
Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma
NCT00587132
Pancreatic Cancer
TERMINATED
PHASE1/PHASE2
A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers
NCT01087801
Pancreatic Disease
COMPLETED
PHASE3
Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection
NCT02160808
Injury of Body of Pancreas
COMPLETED
PHASE2/PHASE3
Cancer of the Pancreas Screening Study (CAPS 3)
NCT00438906
Pancreatic Neoplasm
Peutz-Jeghers Syndrome
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a prospective, phase II exploratory pilot study using different dose frequencies of intravenous human secretin in patients with non-obstructive, interstitial acute pancreatitis. All enrolled patients will receive standard of care therapy in regard to fluid resuscitation, pain control, CT scan or ultrasound imaging and nutritional support. In addition to standard of care, patients will be divided into 4 cohorts of 10 patients. Cohorts 1,2 and 3 will receive different doses of intravenous synthetic human secretin. Cohort X will not receive drug. Dosing will start within 24 hours of hospitalization with no further secretin administration beyond Day 3. Patients will continue to be followed until discharge. The primary study endpoint will be the decrease in serum C-reactive protein (CRP) level by 50% within 96 hours and/or at discharge compared with CRP level at admission to determine optimal frequency of dosing. Secondary study endpoints will include: 1) Serum measurements of pro- and anti-inflammatory cytokines including sCD40L, EGF, Eotaxin/CCL11, FGF-2, Flt-3 ligand, Fractalkine, G-CSF, GM-CSF, GRO, IFN-α2, IFN-γ, IL-1α, IL-1β, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p40), IL-12 (p70), IL-13, IL-15, IL-17A, IP-10, MCP-1, MCP-3, MDC (CCL22), MIP-1α, MIP-1β, PDGF-AA, PDGF-AB/BB, RANTES, TGF-α, TNF-α, TNF-β, VEGF, HSP 27, HSP 60, HSP 70, HSP 90 at time of study enrollment, days of secretin administration, 96 hours and at discharge 2) Clinically relevant outcome measures including hemoconcentration (fall in blood urea nitrogen and hematocrit from admission), decrease in patient admission pain scores (visual analogue scale), decrease in systemic inflammatory response, and tolerance of oral nutrition 3) Calculation of the Dynamic Acute Pancreatitis Score - organ failure, systemic inflammatory response syndrome, abdominal pain, requirement for opiates and ability to tolerate oral intake 4) Length of hospitalization, need for intensive care unit transfer, mortality, need for surgical, endoscopic or percutaneous intervention 5) Development of pancreatic necrosis and/or persistent organ failure and 6) Adverse events and 30 day readmission rate.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Pancreatitis, Acute
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
The study is not blinded and does not require any randomization codes. Ten patients each will receive one of three treatments for Days 1, 2, and 3:
1. No secretin - standard of care and observation (Cohort X)
2. 32 mcg (\<50kg) or 40 mcg (≥50kg)IV Bolus every 12 hours (Cohort 1)
3. 32 mcg (\<50kg) or 40 mcg (≥50kg)IV Bolus every 6 hours (Cohort 2)
4. 32 mcg (\<50kg) or 40 mcg (≥50kg)IV Bolus every 4 hours (Cohort 3)
1. No secretin - standard of care and observation (Cohort X)
2. 32 mcg (\<50kg) or 40 mcg (≥50kg)IV Bolus every 12 hours (Cohort 1)
3. 32 mcg (\<50kg) or 40 mcg (≥50kg)IV Bolus every 6 hours (Cohort 2)
4. 32 mcg (\<50kg) or 40 mcg (≥50kg)IV Bolus every 4 hours (Cohort 3)
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort X
no secretin administered. All observations
Group Type
NO_INTERVENTION
No interventions assigned to this group
Cohort 1
32 mcg (\<50kg) or 40 mcg (≥50kg) secretin two times a day (40 mcg; q 12 hrs)
Group Type
ACTIVE_COMPARATOR
Secretin
Intervention Type
DRUG
Drug to stimulate pancreatic secretion
Cohort 2
32 mcg (\<50kg) or 40 mcg (≥50kg) secretin four times a day (40 mcg; q 6 hrs)
Group Type
ACTIVE_COMPARATOR
Secretin
Intervention Type
DRUG
Drug to stimulate pancreatic secretion
Cohort 3
32 mcg (\<50kg) or 40 mcg (≥50kg) secretin six times a day (40 mcg; q 4 hrs)
Group Type
ACTIVE_COMPARATOR
Secretin
Intervention Type
DRUG
Drug to stimulate pancreatic secretion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Secretin
Drug to stimulate pancreatic secretion
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
ChiRhoStim®
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Patient is male or female ≥18 years of age
2. Patient voluntarily signed written, informed consent agreement.
3. If patient is female and not more than 1 year post-menopausal, or surgically sterile, must use medically accepted form of contraception or abstain from sexual activities during study
4. Patient has acute pancreatitis as defined by the Atlanta Classification of 2012
5. No evidence of obstructive pancreatitis on available cross-sectional imaging
2. Patient voluntarily signed written, informed consent agreement.
3. If patient is female and not more than 1 year post-menopausal, or surgically sterile, must use medically accepted form of contraception or abstain from sexual activities during study
4. Patient has acute pancreatitis as defined by the Atlanta Classification of 2012
5. No evidence of obstructive pancreatitis on available cross-sectional imaging
Exclusion Criteria
1. Pancreatitis with duct obstruction or severe acute pancreatitis defined by Atlanta Classification
2. Pregnant woman, nursing mothers, or women of childbearing potential not on birth control
3. Known adverse reaction to human secretin
2. Pregnant woman, nursing mothers, or women of childbearing potential not on birth control
3. Known adverse reaction to human secretin
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dartmouth-Hitchcock Medical Center
OTHER
Sponsor Role
collaborator
ChiRhoClin, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Timothy B Gardner, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
National Institutes of Health. Opportunities and challenges in digestive diseases research: recommendations of the national commission on digestive diseases. March 2009. Retrieved January 29, 2017.
Reference Type
BACKGROUND
Everhart JE, Ruhl CE. Burden of digestive diseases in the United States Part III: Liver, biliary tract, and pancreas. Gastroenterology. 2009 Apr;136(4):1134-44. doi: 10.1053/j.gastro.2009.02.038. Epub 2009 Feb 24. No abstract available.
Reference Type
BACKGROUND
Forsmark CE, Vege SS, Wilcox CM. Acute Pancreatitis. N Engl J Med. 2016 Nov 17;375(20):1972-1981. doi: 10.1056/NEJMra1505202. No abstract available.
Reference Type
BACKGROUND
Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8.
Reference Type
BACKGROUND
Lerch MM, Saluja AK, Runzi M, Dawra R, Saluja M, Steer ML. Pancreatic duct obstruction triggers acute necrotizing pancreatitis in the opossum. Gastroenterology. 1993 Mar;104(3):853-61. doi: 10.1016/0016-5085(93)91022-a.
Reference Type
BACKGROUND
Rattner DW. Experimental models of acute pancreatitis and their relevance to human disease. Scand J Gastroenterol Suppl. 1996;219:6-9. doi: 10.3109/00365529609104991.
Reference Type
BACKGROUND
Hegyi P, Pandol S, Venglovecz V, Rakonczay Z Jr. The acinar-ductal tango in the pathogenesis of acute pancreatitis. Gut. 2011 Apr;60(4):544-52. doi: 10.1136/gut.2010.218461. Epub 2010 Sep 28.
Reference Type
BACKGROUND
Grady T, Saluja A, Kaiser A, Steer M. Edema and intrapancreatic trypsinogen activation precede glutathione depletion during caerulein pancreatitis. Am J Physiol. 1996 Jul;271(1 Pt 1):G20-6. doi: 10.1152/ajpgi.1996.271.1.G20.
Reference Type
BACKGROUND
Prinz RA. Mechanisms of acute pancreatitis. Vascular etiology. Int J Pancreatol. 1991 Summer;9:31-8. doi: 10.1007/BF02925576.
Reference Type
BACKGROUND
Hegyi P, Rakonczay Z Jr. The role of pancreatic ducts in the pathogenesis of acute pancreatitis. Pancreatology. 2015 Jul;15(4 Suppl):S13-7. doi: 10.1016/j.pan.2015.03.010. Epub 2015 Apr 7.
Reference Type
BACKGROUND
Song L, Wormann S, Ai J, Neuhofer P, Lesina M, Diakopoulos KN, Ruess D, Treiber M, Witt H, Bassermann F, Halangk W, Steiner JM, Esposito I, Rosendahl J, Schmid RM, Riemann M, Algul H. BCL3 Reduces the Sterile Inflammatory Response in Pancreatic and Biliary Tissues. Gastroenterology. 2016 Feb;150(2):499-512.e20. doi: 10.1053/j.gastro.2015.10.017. Epub 2015 Oct 23.
Reference Type
BACKGROUND
Vege SS, Atwal T, Bi Y, Chari ST, Clemens MA, Enders FT. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial. Gastroenterology. 2015 Aug;149(2):318-20.e3. doi: 10.1053/j.gastro.2015.04.019. Epub 2015 Jun 23.
Reference Type
BACKGROUND
Noel P, Patel K, Durgampudi C, Trivedi RN, de Oliveira C, Crowell MD, Pannala R, Lee K, Brand R, Chennat J, Slivka A, Papachristou GI, Khalid A, Whitcomb DC, DeLany JP, Cline RA, Acharya C, Jaligama D, Murad FM, Yadav D, Navina S, Singh VP. Peripancreatic fat necrosis worsens acute pancreatitis independent of pancreatic necrosis via unsaturated fatty acids increased in human pancreatic necrosis collections. Gut. 2016 Jan;65(1):100-11. doi: 10.1136/gutjnl-2014-308043. Epub 2014 Dec 10.
Reference Type
BACKGROUND
Gardner TB, Vege SS, Pearson RK, Chari ST. Fluid resuscitation in acute pancreatitis. Clin Gastroenterol Hepatol. 2008 Oct;6(10):1070-6. doi: 10.1016/j.cgh.2008.05.005. Epub 2008 Jul 10.
Reference Type
BACKGROUND
Pitchumoni CS, Agarwal N, Jain NK. Systemic complications of acute pancreatitis. Am J Gastroenterol. 1988 Jun;83(6):597-606.
Reference Type
BACKGROUND
Chey WY, Chang TM. Secretin: historical perspective and current status. Pancreas. 2014 Mar;43(2):162-82. doi: 10.1097/01.mpa.0000437325.29728.d6.
Reference Type
BACKGROUND
Chey WY, Chang TM. Secretin, 100 years later. J Gastroenterol. 2003;38(11):1025-35. doi: 10.1007/s00535-003-1235-3.
Reference Type
BACKGROUND
Hegyi P, Rakonczay Z. Insufficiency of electrolyte and fluid secretion by pancreatic ductal cells leads to increased patient risk for pancreatitis. Am J Gastroenterol. 2010 Sep;105(9):2119-20. doi: 10.1038/ajg.2010.191. No abstract available.
Reference Type
BACKGROUND
Takacs T, Rosztoczy A, Maleth J, Rakonczay Z Jr, Hegyi P. Intraductal acidosis in acute biliary pancreatitis. Pancreatology. 2013 Jul-Aug;13(4):333-5. doi: 10.1016/j.pan.2013.05.011. Epub 2013 Jun 10.
Reference Type
BACKGROUND
Hegyi P, Petersen OH. The exocrine pancreas: the acinar-ductal tango in physiology and pathophysiology. Rev Physiol Biochem Pharmacol. 2013;165:1-30. doi: 10.1007/112_2013_14.
Reference Type
BACKGROUND
Ishiguro H, Naruse S, Kitagawa M, Mabuchi T, Kondo T, Hayakawa T, Case RM, Steward MC. Chloride transport in microperfused interlobular ducts isolated from guinea-pig pancreas. J Physiol. 2002 Feb 15;539(Pt 1):175-89. doi: 10.1113/jphysiol.2001.012490.
Reference Type
BACKGROUND
Ooi CY, Dorfman R, Cipolli M, Gonska T, Castellani C, Keenan K, Freedman SD, Zielenski J, Berthiaume Y, Corey M, Schibli S, Tullis E, Durie PR. Type of CFTR mutation determines risk of pancreatitis in patients with cystic fibrosis. Gastroenterology. 2011 Jan;140(1):153-61. doi: 10.1053/j.gastro.2010.09.046. Epub 2010 Nov 9.
Reference Type
BACKGROUND
Freedman SD, Kern HF, Scheele GA. Pancreatic acinar cell dysfunction in CFTR(-/-) mice is associated with impairments in luminal pH and endocytosis. Gastroenterology. 2001 Oct;121(4):950-7. doi: 10.1053/gast.2001.27992.
Reference Type
BACKGROUND
Behrendorff N, Floetenmeyer M, Schwiening C, Thorn P. Protons released during pancreatic acinar cell secretion acidify the lumen and contribute to pancreatitis in mice. Gastroenterology. 2010 Nov;139(5):1711-20, 1720.e1-5. doi: 10.1053/j.gastro.2010.07.051. Epub 2010 Aug 3.
Reference Type
BACKGROUND
Hegyi P, Maleth J, Venglovecz V, Rakonczay Z Jr. Pancreatic ductal bicarbonate secretion: challenge of the acinar Acid load. Front Physiol. 2011 Jul 14;2:36. doi: 10.3389/fphys.2011.00036. eCollection 2011.
Reference Type
BACKGROUND
Goldenberg DE, Gordon SR, Gardner TB. Management of acute pancreatitis. Expert Rev Gastroenterol Hepatol. 2014 Aug;8(6):687-94. doi: 10.1586/17474124.2014.907524. Epub 2014 Apr 25.
Reference Type
BACKGROUND
Morimoto T, Noguchi Y, Sakai T, Shimbo T, Fukui T. Acute pancreatitis and the role of histamine-2 receptor antagonists: a meta-analysis of randomized controlled trials of cimetidine. Eur J Gastroenterol Hepatol. 2002 Jun;14(6):679-86. doi: 10.1097/00042737-200206000-00014.
Reference Type
BACKGROUND
Uhl W, Buchler MW, Malfertheiner P, Beger HG, Adler G, Gaus W. A randomised, double blind, multicentre trial of octreotide in moderate to severe acute pancreatitis. Gut. 1999 Jul;45(1):97-104. doi: 10.1136/gut.45.1.97.
Reference Type
BACKGROUND
Andriulli A, Leandro G, Clemente R, Festa V, Caruso N, Annese V, Lezzi G, Lichino E, Bruno F, Perri F. Meta-analysis of somatostatin, octreotide and gabexate mesilate in the therapy of acute pancreatitis. Aliment Pharmacol Ther. 1998 Mar;12(3):237-45. doi: 10.1046/j.1365-2036.1998.00295.x.
Reference Type
BACKGROUND
Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, Smith B, Banks PA, Conwell DL. Lactated Ringer's solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):710-717.e1. doi: 10.1016/j.cgh.2011.04.026. Epub 2011 May 12.
Reference Type
BACKGROUND
Levenick JM, Andrews CL, Purich ED, Gordon SR, Gardner TB. A phase II trial of human secretin infusion for refractory type B pain in chronic pancreatitis. Pancreas. 2013 May;42(4):596-600. doi: 10.1097/MPA.0b013e318273f3ec.
Reference Type
BACKGROUND
Stevens T, Conwell DL, Zuccaro G Jr, Van Lente F, Lopez R, Purich E, Fein S. A prospective crossover study comparing secretin-stimulated endoscopic and Dreiling tube pancreatic function testing in patients evaluated for chronic pancreatitis. Gastrointest Endosc. 2008 Mar;67(3):458-66. doi: 10.1016/j.gie.2007.07.028.
Reference Type
BACKGROUND
Conwell DL, Zuccaro G Jr, Vargo JJ, Trolli PA, Vanlente F, Obuchowski N, Dumot JA, O'laughlin C. An endoscopic pancreatic function test with synthetic porcine secretin for the evaluation of chronic abdominal pain and suspected chronic pancreatitis. Gastrointest Endosc. 2003 Jan;57(1):37-40. doi: 10.1067/mge.2003.14.
Reference Type
BACKGROUND
Renner IG, Wisner JR Jr. Ceruletide-induced acute pancreatitis in the dog and its amelioration by exogenous secretin. Int J Pancreatol. 1986 May;1(1):39-49. doi: 10.1007/BF02795238.
Reference Type
BACKGROUND
Renner IG, Wisner JR Jr, Lavigne BC. Partial restoration of pancreatic function by exogenous secretin in rats with ceruletide-induced acute pancreatitis. Dig Dis Sci. 1986 Mar;31(3):305-13. doi: 10.1007/BF01318123.
Reference Type
BACKGROUND
Niederau C, Ferrell LD, Grendell JH. Caerulein-induced acute necrotizing pancreatitis in mice: protective effects of proglumide, benzotript, and secretin. Gastroenterology. 1985 May;88(5 Pt 1):1192-204. doi: 10.1016/s0016-5085(85)80079-2.
Reference Type
BACKGROUND
Evander A, Lundquist I, Ihse I. Influence of gastrointestinal hormones on the course of acute experimental pancreatitis. Hepatogastroenterology. 1982 Aug;29(4):161-6.
Reference Type
BACKGROUND
Jowell PS, Branch MS, Fein SH, Purich ED, Kilaru R, Robuck G, d'Almada P, Baillie J. Intravenous synthetic secretin reduces the incidence of pancreatitis induced by endoscopic retrograde cholangiopancreatography. Pancreas. 2011 May;40(4):533-9. doi: 10.1097/MPA.0b013e3182152eb6.
Reference Type
BACKGROUND
Bakker OJ, van Brunschot S, van Santvoort HC, Besselink MG, Bollen TL, Boermeester MA, Dejong CH, van Goor H, Bosscha K, Ahmed Ali U, Bouwense S, van Grevenstein WM, Heisterkamp J, Houdijk AP, Jansen JM, Karsten TM, Manusama ER, Nieuwenhuijs VB, Schaapherder AF, van der Schelling GP, Schwartz MP, Spanier BW, Tan A, Vecht J, Weusten BL, Witteman BJ, Akkermans LM, Bruno MJ, Dijkgraaf MG, van Ramshorst B, Gooszen HG; Dutch Pancreatitis Study Group. Early versus on-demand nasoenteric tube feeding in acute pancreatitis. N Engl J Med. 2014 Nov 20;371(21):1983-93. doi: 10.1056/NEJMoa1404393.
Reference Type
BACKGROUND
Eatock FC, Chong P, Menezes N, Murray L, McKay CJ, Carter CR, Imrie CW. A randomized study of early nasogastric versus nasojejunal feeding in severe acute pancreatitis. Am J Gastroenterol. 2005 Feb;100(2):432-9. doi: 10.1111/j.1572-0241.2005.40587.x.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Drug Cohort ICF
Document Type: Informed Consent Form: Observational Cohort ICF
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas
NCT00660335
COMPLETED
PHASE3
Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis
NCT00620919
TERMINATED
PHASE1
Secretin-Assisted Computed Tomography Scan and Magnetic Resonance Imaging in Improving Pancreatic Tumor Conspicuity
NCT01371240
WITHDRAWN
EARLY_PHASE1
Sunitinib and Gemcitabine in Treating Patients With Pancreatic Cancer or Other Solid Tumors
NCT00462553
COMPLETED
PHASE1
Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients
NCT00383760
COMPLETED
PHASE2
Efficacy of Secretin MRCP in the Diagnosis and Follow up of Auto Immune Pancreatitis
NCT01845467
WITHDRAWN
Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis
NCT02743364
COMPLETED
PHASE2
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
NCT00336700
TERMINATED
PHASE2
Secretin-enhanced Magnetic Resonance Imaging (S-MRI) for Pancreatic Cancer Detection
NCT01094626
WITHDRAWN
NA
Imaging Biomarkers of Pancreatic Function and Disease
NCT05659147
ENROLLING_BY_INVITATION
PHASE4
A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died
NCT00061438
COMPLETED
PHASE4
Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind, Placebo-controlled, Multi-centre Trial (RAPID-I)
NCT03684278
RECRUITING
PHASE2
A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer
NCT00557596
TERMINATED
PHASE1/PHASE2
PROOF: Pancreatitis-associated Risk Of Organ Failure
NCT03075605
COMPLETED
A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
NCT06080789
RECRUITING
PHASE2
Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis
NCT03634787
UNKNOWN
Study of Sirolimus in Patients With Advanced Pancreatic Cancer
NCT03662412
UNKNOWN
PHASE1/PHASE2
DP-b99 in the Treatment of Acute High-risk Pancreatitis
NCT02025049
TERMINATED
PHASE2
CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
NCT03401190
COMPLETED
PHASE2
Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis
NCT05551858
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
NCT01020006
COMPLETED
PHASE2
Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
NCT05069597
COMPLETED
PHASE4
Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences 2
NCT03075631
COMPLETED
Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma
NCT05363007
UNKNOWN
PHASE2
p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Pancreatic Cancer
NCT02847000
COMPLETED
EARLY_PHASE1