Evidence Based Management of Acute Biliary Pancreatitis
1 other identifier
observational
30
1 country
1
Brief Summary
This study aims to assess the outcome of standardized evidence-based care to all patients with acute biliary pancreatitis treated at surgery department, Zagazig University hospitals during the period from may, 2017 to may 2019.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedFirst Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedNovember 5, 2020
November 1, 2020
2 years
October 21, 2020
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
success rate of minimally invasive techniques (percutaneaous catheter drainage, endoscopic approach and retroperitoneal approach) in cases with infected walled off necrosis
Data were tabulated and statistically analyzed in terms of percentages Success of the intervention means patient condition improves \[clinical (vital signs) , laboratory (CBC, kidney and liver function tests) and radiological improvement (no residual collection in CT)\] and that there is no need for further intervention to control the disease till patient discharge
immediately following intervention to 6 weeks following intervention
rate of complications of minimally invasive techniques used in the management of cases with infected walled off necrosis including bleeding, fistula, wound infection, incisional hernia
Data were tabulated and statistically analyzed in terms of percentages
up to 6 months following intervention
Mortality rate of acute biliary pancreatitis in the study period
Data were tabulated and statistically analyzed in terms of percentages
from admission to 6 months following admission
length of hospital stay of mild and severe cases with acute biliary pancreatitis
Data were tabulated and statistically analyzed in terms of frequencies length of hospital stay in days
up to 6 months
Secondary Outcomes (2)
age of cases with acute biliary pancreatitis in Sharqia in years
at admission
Sex of cases with acute biliary pancreatitis in Sharqia (Males and females)
at admission
Study Arms (1)
application of recent guidelines in the management of acute biliary pancreatitis
all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
Interventions
Laboratory ( elevated serum lipase or amylase at least 3 times above the normal limits) is helpful in diagnosis Acute pancreatitis is diagnosed when two of three criteria are present including: 1. Clinically (abdominal pain consistent with acute pancreatitis), 2. Laboratory ( elevated serum lipase or amylase at least 3 times above the normal limits) 3. Imaging criteria of acute pancreatitis
helpful in diagnosis of acute pancreatitis and its etiology (Gallstones)
helpful in diagnosis of acute pancreatitis and its etiology . assist in detection of type and severity of acute pancreatitis
help in diagnosis of the etiology of acute pancreatitis elevated Bilirubin, ALT, AST and alkaline phosphatase suggest biliary pancreatitis
helpful in idiopathic acute pancreatitis diagnosis
The initial infusion rate for mild cases : * For patients without dehydration is (130-150mL/h). * In case of dehydration: (150-600mL/h) with close monitoring of patients with comorbidities such as cardiac problems or renal failure to avoid volume overload. The initial infusion rate for both severe cases : * For patients without dehydration is (130-150mL/h). * In case of dehydration/ shock: (150-600mL/h) with close monitoring of patients with comorbidities such as cardiac problems or renal failure to avoid volume overload d. The target * A mean arterial pressure of 65mmHg or more, * Urine output of 0.5mL/kg per hour or more When these parameters achieved, the infusion rate decreased to the level that maintain these parameters.
Pain control (Modified World Health organization (WHO) analgesia ladder) Step1: NSAID / paracetamol Paracetamol 1gm IV infusion /8h + Diclofenac sodium 75mg /12h. Step 2: Opiates +/- NSAID/ paracetamol Pethidine 25 mg IV/4h Step 3: Interventional treatment (epidural analgesia) +/- opiates +/- NSAID/ paracetamol In case of severe pain not responding to the above analgesia
* Mild attack: no antibiotic prophylaxis administered. * Severe attack: * Timing: Antibiotic prophylaxis administered to cases presented early within 72 hrs of disease onset. * Duration: Not more than 2 weeks * Antibiotics given: * Quinolones + Metronidazole ( the 1st choice in ward) Ciprofloxacin 400mg IV /12 h + metronidazole 500mg IV/8h * Carbapenems ± Metronidazole (the 1st choice in ICU patients and in case of sensitivity to quinolones) Imipenem .5gm IV/6h + metronidazole 500mg IV/8h b. Therapeutic (in cases with pancreatic or extrapancreatic infections) * In case of pancreatic infection, Carbapenems ± metronidazole were given.
Severe cases Timing: Within at least 48 hrs of admission provided that there are no intestinal complications. Route: Nasogastric tube Nutrients: Polymeric feeding formula * Nutrient: Fresubin 2Kcal fiber drink 200ml (2Kcal/ml) * Total caloric requirements ꞊ body weight (kg) X 30Kcal/day Pattern : Continuous infusion * The nutrition started with small amount and increased gradually over 16hrs * Infusion rate ꞊ Total caloric requirements / 16hrs
in case of ileus or vomiting
* General anesthesia , Supine position with 30 degree tilt towards the right side * A left subcostal 5 cm incision is performed one finger below the left costal margin over the midaxillary line and the muscles were divided sequentially * Then, aspiration is done from the possible collection. * After confirmation that it was the site of the collection, the fibrotic thick wall was opened by a scissor, as the collection is opened, pus drained spontaneously. * At first, a wide suction was introduced in the cavity and the friable loose necrotic tissue was aspirated. Then, a circuit of flushing saline was created in the residual cavity by injection of saline through the previously placed PCD followed by aspiration of the saline and detached loose necrotic tissue fragments by the wide suction tube * After completion of the procedure, large bore surgical drain was placed into the collection. The fascia was closed over the drains. The skin closed by interrupted sutures
Open necrosectomy was done after failure of the minimally invasive techniques. The procedure was done under general anesthesia under the coverage of Tienam (.5gm/6h IV) following the results of culture and sensitivity of the percutaneous drain effluent Surgical exploration of the peritoneal cavity was done through midline exploratory incision, there were 2 large pus collections extending from the Rt. and Lt. Lumber regions deep down into the pelvis, the intervening septa were divided and the pus was aspirated by a wide suction drain. The lesser sac was opened and necrosectomy was done The previously placed PCD repositioned in the site of necrosectomy as a port for continuous irrigation while a wide tube drain was placed in the lesser sac for drainage. Another 2 tube drains were placed in the pelvis.
for pancreatic pseudocyst Antibiotic prophylaxis with Ciprofloxacin 400mg IV /12 hour was administered before the procedure and continued for 5 days after the procedure At first the cyst morphology was evaluated by EUS and color Doppler ultrasound is used to identify nearby vessels The puncture was performed using a 19-gauge needle, which was introduced into the pseudocyst via a therapeutic linear array echoendoscope. Then, a 0.035-inch guidewire was introduced through the needle and coiled within the pseudocyst under fluoroscopic guidance. The needle was removed and a 10F cystotome was advanced over the guidewire and the tract was dilated by the cystotome, after dilatation, a 10F double-pigtail stent was placed and a sample of the aspirate is sent for chemical and microbiological analysis
for pancreatic pseudocyst general anesthesia, 1 gm of cefotax was given IV at the induction of anaesthesia, supine position over the operating table A transverse supraumbilical incision was performed. A 5 cm horizontal anterior gastrotomy was performed (Image 23a). Hemostasis of the submucosal vessels was performed before the incision of the gastric mucosa. First, the cyst was punctured followed by an incision of 5 cm at the posterior gastric wall. Aspiration of the cyst content was done for chemical and microbiological analysis The wall of the pseudocyst is hemmed to the gastric wall with continuous sutures made of a vicryl 2/0 alongside the entire circumference of the orifice Nasogastric tube was placed in the stomach. The procedure was completed by suturing the anterior gastrotomy with a vicryl 2/0 continous sutures in 2 layers A tube drain was inserted at the pelvis with closure of the abdominal wound in a standard way.
PCD * The percutaneous drainage catheter placed through peritoneal approach under US guidance, the drain size was 12 F. * After placement of the percutaneous catheter, aspirate was sent for microbiological assessment * The PCD was flushed with 50 ml saline, three times daily to keep the drain open and improve lavage of the collection
endoscopic approach it was done to one patient in the form of EUS guided aspiration of pus in a case with infected necrosis followed by percutaneous US guided aspiration of the residual
Eligibility Criteria
All cases with acute biliary pancreatitis admitted to surgery department in the study period were included in the study
You may qualify if:
- all cases with acute biliary pancreatitis
You may not qualify if:
- all cases with non biliary pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zagazig University Faculty of Human Medicine
Zagazig, 44519, Egypt
Related Publications (4)
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PMID: 23100216BACKGROUNDIsaji S, Takada T, Mayumi T, Yoshida M, Wada K, Yokoe M, Itoi T, Gabata T. Revised Japanese guidelines for the management of acute pancreatitis 2015: revised concepts and updated points. J Hepatobiliary Pancreat Sci. 2015 Jun;22(6):433-45. doi: 10.1002/jhbp.260.
PMID: 25904407RESULTTenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
PMID: 23896955RESULTWorking Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
PMID: 24054878RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
yasmine Hegab
zagazig university faculty of human medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
October 21, 2020
First Posted
November 4, 2020
Study Start
May 15, 2017
Primary Completion
May 15, 2019
Study Completion
May 15, 2019
Last Updated
November 5, 2020
Record last verified: 2020-11