Evidence Based Management of Acute Biliary Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

Evidence Based Management of Acute Biliary Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615702
• Other study ID #: acute panreatitis guidelines
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: November 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Acute pancreatitis (AP) is one of the most important gastrointestinal disorders causing emotional and physical human burden . The annual incidence worldwide for AP is 4.9-73.4 cases per 100,000 people and the overall mortality rate is 4 to 8%, which increases to 33% in patients with infected necrosis. AP is diagnosed when two of three criteria are fulfilled: typical abdominal pain of AP, more than three times elevated serum amylase/lipase level and signs of AP on imaging.

It is necessary to clarify the etiology of AP promptly. The diagnosis of gallstones, as the leading cause for AP, should have the top priority as that will direct the treatment policy. Long standing alcohol consumption and gallstones disease incriminated in the majority of cases with AP. Small common bile duct stones, in particular, are the cause of AP in approximately 32 to 40% of cases. In 10-30% of cases, the cause is unknown, so studies have suggested that up to 70% of cases of idiopathic pancreatitis are secondary to biliary microlithiasis.

The pathogenesis of biliary AP has been intensively investigated. Many theories explain how gallstones can trigger AP. The predominant theories include common pathway theory and gallstone migration theory. In general, AP occurs when intracellular protective mechanisms fail to prevent trypsinogen activation or reduce trypsin activity.

It is important that management of such potentially life threatening condition to be guided by an evidence-based approach. After comparing the Japanese (JPN) Guidelines 2015 and its former edition 2010 with the other two guidelines, International Association of Pancreatology/American Pancreas Association guidelines (IAP/APA), 2013 and American College of Gastroenterology (ACG), 2013, the JPN Guidelines, 2015 proved to be the highest quality regarding its systematic literature review prepared by the meta-analysis team, including the grading of recommendations and providing pancreatitis bundles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all cases with acute biliary pancreatitis

Exclusion Criteria:

• all cases with non biliary pancreatitis

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Diagnostic Test:
• serum lipase or amylase
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: Clinically (abdominal pain consistent with acute pancreatitis), Laboratory ( elevated serum lipase or amylase at least 3 times above the normal limits) Imaging criteria of acute pancreatitis

Device:
• ultrasound
helpful in diagnosis of acute pancreatitis and its etiology (Gallstones)
• CT
helpful in diagnosis of acute pancreatitis and its etiology . assist in detection of type and severity of acute pancreatitis

Diagnostic Test:
• Liver enzymes (Bilirubin, alanine transferase (ALT), aspartate aminotransferase, (AST) and alkaline phosphatase). Calcium. Triglycerides.
help in diagnosis of the etiology of acute pancreatitis elevated Bilirubin, ALT, AST and alkaline phosphatase suggest biliary pancreatitis

Device:
• EUS /Secretin-stimulated magnetic resonance cholangiopancreatography (MRCP)
helpful in idiopathic acute pancreatitis diagnosis

Drug:
• Ringer lactate
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.

Combination Product:
• NSAID / paracetamol +/- opiates+/- epidural analgesia
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
• Quinolones + Metronidazole /Carbapenems ± Metronidazole
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.

Dietary Supplement:
• Fresubin 2Kcal fiber drink
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

Device:
• nasogastric tube
in case of ileus or vomiting

Procedure:
• retroperitoneal necrosectomy
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
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.
• Endoscopic transmural cystogastrostomy
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
• open cystogastrostomy
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.
• percutaneous catheter drainage (PCD) for infected necrosis
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 ultrasound (EUS) guided aspiration for infected necrosis
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

Locations

Country	Name	City	State
Egypt	Zagazig University Faculty of Human Medicine	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Isaji 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/jh — View Citation

Tenner 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. — View Citation

Working 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	age of cases with acute biliary pancreatitis in Sharqia in years	Data were tabulated and statistically analyzed in terms of mean	at admission
Secondary	Sex of cases with acute biliary pancreatitis in Sharqia (Males and females)	Data were tabulated and statistically analyzed in terms of percentages	at admission