Evidence Based Management of Acute Biliary Pancreatitis

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: All cases with acute biliary pancreatitis admitted to surgery department in the study period were included in the study

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Acute Pancreatitis

Being tested

serum lipase or amylase, ultrasound, CT, Liver enzymes (Bilirubin, alanine transferase (ALT), aspartate aminotransferase, (AST) and alkaline phosphatase). Calcium. Triglycerides., EUS /Secretin-stimulated magnetic resonance cholangiopancreatography (MRCP)

Keywords

acute pancreatitis guidelines, acute biliary pancreatitis

Medical subject headings

Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• serum lipase or amylaseDiagnostic test

  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

• ultrasoundDevice

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

• CTDevice

  helpful in diagnosis of acute pancreatitis and its etiology . assist in detection of type and severity of acute pancreatitis

• Liver enzymes (Bilirubin, alanine transferase (ALT), aspartate aminotransferase, (AST) and alkaline phosphatase). Calcium. Triglycerides.Diagnostic test

  help in diagnosis of the etiology of acute pancreatitis elevated Bilirubin, ALT, AST and alkaline phosphatase suggest biliary pancreatitis

• EUS /Secretin-stimulated magnetic resonance cholangiopancreatography (MRCP)Device

  helpful in idiopathic acute pancreatitis diagnosis

• Ringer lactateDrug

  Also called hartmann's solution

  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.

• NSAID / paracetamol +/- opiates+/- epidural analgesiaCombination product

  Also called NSAID (Diclofenac sodium) paracetamol (perfalgan drip) Opiates (Pethidine)

  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 ± MetronidazoleCombination product

  Also called Quinolones (ciprofloxacin) Metronidazole (flagyl) Carbapenems (Imipenem)

  • 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

  1. Therapeutic (in cases with pancreatic or extrapancreatic infections)

  • In case of pancreatic infection, Carbapenems ± metronidazole were given.

• Fresubin 2Kcal fiber drinkDietary supplement

  Also called polymeric feeding formula

  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

• nasogastric tubeDevice

  in case of ileus or vomiting

• retroperitoneal necrosectomyProcedure or surgery

  • 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 necrosectomyProcedure or surgery

  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 cystogastrostomyProcedure or surgery

  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 cystogastrostomyProcedure or surgery

  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 necrosisProcedure or surgery

  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 necrosisProcedure or surgery

  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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

   Measured: immediately following intervention to 6 weeks following intervention

2. 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

   Measured: up to 6 months following intervention

3. Mortality rate of acute biliary pancreatitis in the study period

   Data were tabulated and statistically analyzed in terms of percentages

   Measured: from admission to 6 months following admission

4. 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

   Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted4 Nov 2020
2. Study start15 May 2017
3. Primary completion15 May 2019
4. Study completion15 May 2019

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (4)Papers the sponsor has linked to this study.
• Other trials for Acute PancreatitisStudies of the same condition, open and under way.
• More trials run by Zagazig UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.