Laparoscopic Cystogastrostomy Versus Endoscopic Cystogastrostomy
Condition: Pancreatic Pseudocyst
MeSH terms: Pancreatic Pseudocyst
Study type: Interventional

Summary: 
      This study is a randomized controlled trial comparing Laparoscopic and endoscopic drainage
      for pseudocyst of the pancreas secondary to acute pancreatitis. The primary outcome measure
      will be resolution of the pseudocyst by the intended treatment within 4 weeks. The secondary
      outcomes will be complications, recurrence and cost analysis between the two methods.
    

Detailed description: 
      This study will be conducted in the Department of Surgical Disciplines and Department of
      Gastroenterology, All India Institute of Medical Sciences, New Delhi. Patients with
      pancreatic pseudocyst will be randomized to two groups-

      Group I- Laparoscopic management of the pseudocyst Group II- Endoscopic management of the
      pseudocyst

      Patients will be randomized using computer generated randomized numbers in sealed envelopes
      to ensure concealed allocation with block randomization. The details of patients who do not
      meet inclusion criteria and those who refuse consent and reason for refusal of consent will
      also be noted. Refusal for consent for inclusion in the study will not hamper the treatment
      of these patients in anyway. The patients will be evaluated prospectively. CONSORT guidelines
      will be followed.

      Preoperative Data

      The details regarding demographic profile of the patient i.e. age/ sex/ body mass index (BMI)
      and clinical features will be noted. The duration and presenting complaint for pseudocyst and
      history regarding the acuteness of underlying pancreatic disease will be noted. The etiology
      of pancreatitis will be noted. Patients will be examined thoroughly and the characteristic
      features of the pseudocysts, the size and the site (head, body or tail of the pancreas) will
      be noted. The American Society of Anesthesiologists (ASA) grading of the patient will also be
      done.

      Pre-operative Investigations

      Preoperative investigations will include hemogram, liver function tests, serum electrolytes,
      serum amylase, serum lipase, kidney function tests, chest X-ray and electrocardiogram.
      Ultrasound of the abdomen, and contrast enhanced computer tomography (CECT) will be done for
      proper localization, size, wall characteristics, presence or absence of pseudoaneurysm and
      relationship of the cyst with the surrounding structures. Magnetic Resonance Imaging (MRI)
      will be done to asses the relative amount of necrotic debris within the cyst, if required. An
      Endoscopic ultrasound will be done at the discretion of the gastroenterologist for planning
      endoscopic drainage of the pseudocyst.

      A clinical case record (CRF) form will be filled with all the relevant details.

      INTERVENTION TECHNIQUE

      Laparoscopic Cystogastrostomy

      Pre-operative Preparation

      One dose of injection cefoperazone 1000 mg + sulbactam 1000 mg after skin test, one dose of
      metronidazole 500 mg and Amikacin 1000 mg will be given intravenously as prophylaxis
      pre-operatively at the time of induction of anesthesia. The antibiotics will be continued for
      3 days after surgery. A 14 Fr Foley's catheter will be placed pre-operatively after induction
      of anesthesia.

      Operative Procedure

      Patient will be placed in Lloyd-Davis position with both upper limbs by side of the patient.
      General anesthesia with or without supplementation with spinal anesthesia will be given to
      all patients. A 12 mm camera port at umbilicus, one 5 mm port in the left pararectal region,
      one 12 mm port in the right pararectal area at the level of umbilicus and the fourth port in
      the epigastric region for puncturing and aspirating the pseudocyst. 2-3 ml of 0.25%
      bupivacaine will be infiltrated at each port site for local anesthesia before port placement.
      Pneumoperitoneum will be created using veress needle. The first port will be inserted in a
      closed manner and directed towards the upper abdomen. The bulge of the pseudocyst on the
      posterior wall of the stomach will be identified and access to the posterior gastric wall
      will be established through an anterior gastrotomy (2 -2.5 cm) created with the help of
      harmonic shears/monopolar hook knife. A long needle will be introduced to confirm the
      location of the pseudocyst and to sample the fluid. A bariatric port will be introduced
      through the posterior wall of the stomach into the cyst and its contents aspirated. The cyst
      will then be irrigated through the port and debris cleared. The cystogastrostomy stoma will
      be made with endostapler (Ethicon Endo-surgery, Cincinnati). Gastrotomy will be closed in two
      layers with intracorporeal suturing. Cholecystectomy will be done if necessary using the
      standard four port technique. A 16 F drain will be placed in the subhepatic space.

      Details of any associated procedures like cholecystectomy, laparoscopic CBD exploration or
      any other procedure will be recorded and details noted thereof.

      Endoscopic Cystogastrostomy

      Preprocedural preparation

      One dose of injection cefoperazone 1000 mg + sulbactam 1000 mg after skin test will be given
      intravenously as prophylaxis before the procedure and will be continued for up to 3 days
      after the procedure or as required.

      Procedure

      The ideal site of puncture will be determined by the site of maximum bulge on the posterior
      gastric wall. A needle knife will be used to puncture into the gastric or cyst wall with the
      help of electrocoagulation. A gush of cyst fluid will be encountered when the cyst is
      entered. A guide wire will be then passed through the needle knife. A balloon will be used to
      dilate the opening up to 15 mm without cutting. One 10 Fr plastic double pigtail stent will
      be placed into the pseudocyst. The stent will be removed three months later. If there is no
      bulge on endoscopic view, cystogastrostomy will be done under endoscopic ultrasonography
      guidance.

      In the presence of necrotic debris if a patient develops fever, a repeat procedure will be
      done within three days. An 8.8 mm diameter, size forward viewing endoscope will be used to
      enter the cavity. The cavity will be lavaged with saline and loose necrotic tissue will be
      removed with snare or basket.

      Operative data will be recorded in a preformed proforma on port placements, mode of
      gastrotomy, location of the pseudocyst, operation time, associated procedures performed,
      conversion to open, any intraoperative complication and other intra-operative details.
      Reasons for conversion to open and procedure performed after conversion will also be
      recorded. Data regarding endoscopic procedure will also be recorded in a prestructured
      proforma on the technique, mode of gastrotomy, procedure time, any complication encountered
      during the procedure and other intraprocedural details. The number of procedures and hospital
      stay will be recorded.

      Details of any associated procedures like endoscopic retrograde cholangiopancreaticography
      (ERCP) or Common bile duct (CBD) stone removal will be recorded. An ERCP will not be done
      routinely prior to drainage to find out any communication of the cyst with main pancreatic
      duct (MPD). In patients with recurrence within four weeks an ERCP will be done to rule out
      ductal communication and a pancreatic stent will be placed if a fistula is found in both
      surgical and endoscopic groups.

      Post intervention Evaluation

      Data regarding post operative/post endoscopic recovery and complications such as bleeding,
      wound infection, haematemesis, fever, intra abdominal collection and any drainage performed
      will be collected. Post operative/post procedural amylase levels and ultrasound findings will
      also be recorded.

      Hospital Stay

      Post procedure hospital stay would be recorded in days. Follow up

      All patients will be followed up in the post operative period for at least 3 months. The
      first follow up will be at seven days, then at 4 weeks and then 3 months after surgery. An
      ultrasound will be done at each follow up to look for cyst recurrence or any other
      intra-abdominal problem. A note of any additional procedures or admissions after the index
      intervention will be made.

      Cost of procedure

      This includes both direct and indirect costs incurred by the patient and the hospital for the
      procedure.

      Statistical analysis

      The data will be entered into Microsoft excel software and will be analyzed by using
      Statistical Package for the Social Sciences (SPSS) software version 15. The statistical
      method applied will be student t-test/ Mann Whitney U test, whichever is applicable to
      compare the continuous data between the two groups and the categorical variables will be
      compared using Chi - Square test/ Fisher exact test. A P-value of <0.05 will be considered as
      significant.
    

Intervention name(s): Laparoscopic cystogastrostomy; Endoscopic cystogastrostomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients undergo drainage of pseudocyst by laparoscopic technique; Endoscopic cystogastrostomy or cystoduodenostomy will be performed either under direct endoscopic or endosonography guidance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute pancreatitis; Pseudocyst