Current partner codePEPTIDESDE
NCT04615702·Not applicable·OBSERVATIONAL

Evidence Based Management of Acute Biliary Pancreatitis

Status

Completed

Phase

Not applicable

Enrollment

30

Locations

1

Results

Not posted

Publications

4

Study summary

What the protocol is testing.

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.

Full detailed 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.

Interventions

Treatment arms and agents.

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: 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

DEVICE

ultrasound

helpful in diagnosis of acute pancreatitis and its etiology (Gallstones)

DEVICE

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

COMBINATION_PRODUCT

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

PROCEDURE

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.

Timeline

From registration to results.

  1. First posted

    Nov 4, 2020

  2. Study start

    May 15, 2017

  3. Primary completion

    May 15, 2019

  4. Study completion

    May 15, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Nov 5, 2020

Outcomes

What the study measures.

Primary outcomes

success rate of minimally invasive techniques (percutaneaous catheter drainage, endoscopic approach and retroperitoneal approach) in cases with infected walled off necrosis

Time frame · immediately following intervention to 6 weeks following intervention

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

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

Time frame · up to 6 months following intervention

Data were tabulated and statistically analyzed in terms of percentages

Mortality rate of acute biliary pancreatitis in the study period

Time frame · from admission to 6 months following admission

Data were tabulated and statistically analyzed in terms of percentages

length of hospital stay of mild and severe cases with acute biliary pancreatitis

Time frame · up to 6 months

Data were tabulated and statistically analyzed in terms of frequencies length of hospital stay in days

Secondary outcomes

age of cases with acute biliary pancreatitis in Sharqia in years

Time frame · at admission

Data were tabulated and statistically analyzed in terms of mean

Sex of cases with acute biliary pancreatitis in Sharqia (Males and females)

Time frame · at admission

Data were tabulated and statistically analyzed in terms of percentages

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * all cases with acute biliary pancreatitis Exclusion Criteria: * all cases with non biliary pancreatitis

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Zagazig University Faculty of Human Medicine

Zagazig, Egypt

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