gabexate and Hyperamylasemia studies

Gabexate: A serine proteinase inhibitor used therapeutically in the treatment of pancreatitis, disseminated intravascular coagulation (DIC), and as a regional anticoagulant for hemodialysis. The drug inhibits the hydrolytic effects of thrombin, plasmin, and kallikrein, but not of chymotrypsin and aprotinin.

Hyperamylasemia: A condition with abnormally elevated level of AMYLASES in the serum. Hyperamylasemia due to PANCREATITIS or other causes may be differentiated by identifying the amylase isoenzymes.

Research Excerpts

Excerpt	Relevance	Reference
"No significant difference in the occurrence of pancreatitis, hyperamylasemia, or abdominal pain was observed among placebo-, gabexate-, and somatostatin-treated patients."	10.20	Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter, placebo-controlled, randomized clinical trial. ( Andriulli, A; Clemente, R; De Maio, G; Leandro, G; Leo, P; Perri, F; Sigillito, A; Solmi, L; Suriani, R; Terruzzi, V, 2002)
"The objective of the present study was to determine the efficacy of prophylactic administration of gabexate for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, hyperamylasemia and pancreatic pain."	9.12	Clinical trial of gabexate in the prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis. ( Ge, ZZ; Wu, SM; Xiong, GS; Zhang, XW, 2006)
"Our purpose was to update the meta-analysis on somatostatin (SS, 16 studies) or gabexate mesylate (GM, 9 studies) prophylaxis of post-ERCP pancreatitis and to run sensitivity analyses by subgrouping trials according to schedules of drug administration."	8.84	Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated meta-analysis. ( Andriulli, A; Annese, V; Federici, T; Forlano, R; Iacobellis, A; Ippolito, A; Leandro, G, 2007)
"Routine gabexate prophylaxis was associated with a significant reduction of post-ERCP pancreatitis rate, severe hyperamylasaemia and hospitalisation-related costs only in high-risk patients."	7.73	Frequency of post-ERCP pancreatitis in a single tertiary referral centre without and with routine prophylaxis with gabexate: a 6-year survey and cost-effectiveness analysis. ( Curioni, S; Mariani, A; Masci, E; Testoni, PA, 2006)
"No significant difference in the occurrence of pancreatitis, hyperamylasemia, or abdominal pain was observed among placebo-, gabexate-, and somatostatin-treated patients."	6.20	Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter, placebo-controlled, randomized clinical trial. ( Andriulli, A; Clemente, R; De Maio, G; Leandro, G; Leo, P; Perri, F; Sigillito, A; Solmi, L; Suriani, R; Terruzzi, V, 2002)
"The objective of the present study was to determine the efficacy of prophylactic administration of gabexate for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, hyperamylasemia and pancreatic pain."	5.12	Clinical trial of gabexate in the prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis. ( Ge, ZZ; Wu, SM; Xiong, GS; Zhang, XW, 2006)
"Our purpose was to update the meta-analysis on somatostatin (SS, 16 studies) or gabexate mesylate (GM, 9 studies) prophylaxis of post-ERCP pancreatitis and to run sensitivity analyses by subgrouping trials according to schedules of drug administration."	4.84	Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated meta-analysis. ( Andriulli, A; Annese, V; Federici, T; Forlano, R; Iacobellis, A; Ippolito, A; Leandro, G, 2007)
"Routine gabexate prophylaxis was associated with a significant reduction of post-ERCP pancreatitis rate, severe hyperamylasaemia and hospitalisation-related costs only in high-risk patients."	3.73	Frequency of post-ERCP pancreatitis in a single tertiary referral centre without and with routine prophylaxis with gabexate: a 6-year survey and cost-effectiveness analysis. ( Curioni, S; Mariani, A; Masci, E; Testoni, PA, 2006)

Research

Studies (5)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

The Length of Stay (LOS) of Participants After ERCP if Medical Care is Sought as Assessed in Days

The Number of Participants Who Undergo Surgery After ERCP, as Assessed by Surgical Operative Report

The Number of Participants Who Were Readmitted After ERCP as Assessed by Medical Record and Patients Self-reporting

The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal

The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	5 (100.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Andriulli, A	2
Clemente, R	1
Solmi, L	1
Terruzzi, V	1
Suriani, R	1
Sigillito, A	1
Leandro, G	2
Leo, P	1
De Maio, G	1
Perri, F	1
Xiong, GS	1
Wu, SM	1
Zhang, XW	1
Ge, ZZ	1
Testoni, PA	1
Mariani, A	1
Masci, E	1
Curioni, S	1
Hellmig, S	1
Fölsch, UR	1
Federici, T	1
Ippolito, A	1
Forlano, R	1
Iacobellis, A	1
Annese, V	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial[NCT04559867]		538 participants (Anticipated)	Interventional	2020-09-10	Recruiting
Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) - Induced Pancreatitis Using Aggressive Lactated Ringer's Infusion and/or Rectal Indomethacin[NCT02641561]	Phase 3	192 participants (Actual)	Interventional	2014-10-31	Completed
Tailored Hydration for the Prevention of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis[NCT03561441]		350 participants (Actual)	Interventional	2019-01-01	Completed
Feasibility Study of a Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis[NCT01758549]		62 participants (Actual)	Interventional	2012-07-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	days (Mean)
A (NS+Placebo)	2.3
B (NS+IND)	2.2
C (LR+Placebo)	1.9
D (LR+IND)	4.3

Intervention	Participants (Count of Participants)
A (NS+Placebo)	0
B (NS+IND)	0
C (LR+Placebo)	0
D (LR+IND)	0

Intervention	Participants (Count of Participants)
A (NS+Placebo)	6
B (NS+IND)	2
C (LR+Placebo)	2
D (LR+IND)	1

Intervention	Participants (Count of Participants)
A (NS+Placebo)	10
B (NS+IND)	6
C (LR+Placebo)	9
D (LR+IND)	3

Imaging may include Computer Tomography (NCT02641561)
Timeframe: 30 days after ERCP

The Number of Participants With Acute Respiratory Distress Syndrome (ARDS) After ERCP as Assessed by ARDSnet Criterion (Below)

Intervention	Participants (Count of Participants)
A (NS+Placebo)	0
B (NS+IND)	1
C (LR+Placebo)	0
D (LR+IND)	1

bilateral opacities on chest imaging not explained by other lung pathology, respiratory failure not explained by heart failure or volume, and overload and a pulmonary arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio under 300, PaO2/FiO2 ratio is the partial pressure arterial oxygen and fraction of inspired oxygen (NCT02641561)
Timeframe: 30 days after ERCP

The Number of Participants With Mortality After ERCP as Assessed by Medical Record Reporting

The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated Creatinine Blood Test

Intervention	Participants (Count of Participants)
A (NS+Placebo)	1
B (NS+IND)	0
C (LR+Placebo)	0
D (LR+IND)	0

Intervention	Participants (Count of Participants)
A (NS+Placebo)	1
B (NS+IND)	2
C (LR+Placebo)	2
D (LR+IND)	1

creatinine > 1.5 milligrams/deciliter (mg/dL) (NCT02641561)
Timeframe: 30 days after ERCP

The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated International Normalized Ratio (INR)

The Number of Participants With Pancreatic Abscess After ERCP as Assessed by Abdominal Imaging Suggestive of Pancreatic Abscess

Intervention	Participants (Count of Participants)
A (NS+Placebo)	0
B (NS+IND)	1
C (LR+Placebo)	0
D (LR+IND)	0

Intervention	Participants (Count of Participants)
A (NS+Placebo)	0
B (NS+IND)	0
C (LR+Placebo)	0
D (LR+IND)	0

Imaging may include Computer Tomography (NCT02641561)
Timeframe: 30 days after ERCP

The Number of Participants With Pancreatic Pseudocyst After ERCP as Assessed by Abdominal Imaging Suggestive of Pseudocyst

Intervention	Participants (Count of Participants)
A (NS+Placebo)	0
B (NS+IND)	0
C (LR+Placebo)	0
D (LR+IND)	0

Imaging may include Computer Tomography (NCT02641561)
Timeframe: 30 days after ERCP

The Number of Participants With Perforation After ERCP as Assessed by Abdominal Imaging Suggestive of Perforation

Intervention	Participants (Count of Participants)
A (NS+Placebo)	0
B (NS+IND)	0
C (LR+Placebo)	0
D (LR+IND)	1

Imaging may include Computer Tomography (NCT02641561)
Timeframe: 30 days after ERCP

The Number of Participants With Post-procedural Medical Care (ED Visit, Urgent Care, Hospitalization) as Assessed by Medical Record and Patients Self-reporting

The Number of Participants With Sepsis After ERCP as Assessed by Infectious Source Defined by Positive Microbiology Culture