Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Rare Diseases

Pancreatitis

Pancreatic Pseudocyst

Cysts

Pancreatic Cyst

Pancreatic Diseases

Gastrointestinal Diseases

Acute Graft Versus Host Disease

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Laparoscopic cystogastrostomy will be performed by using a stapled cystogastrostomy

Endoscopic cystogastrostomy or cystoduodenostomy will be performed either under direct endoscopic or endosonography guidance.

Patients undergo drainage of pseudocyst by laparoscopic technique

Laparoscopic cystogastrostomy

Endoscopic cystogastrostomy or cystoduodenostomy will be performed either under direct endoscopic or endosonography guidance

Endoscopic cystogastrostomy

Virinder K Bansal, MS

Pramod K Garg, MD

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.

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.

Laparoscopic Cystogastrostomy Versus Endoscopic Cystogastrostomy

A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Endoscopic Drainage for Pseudocyst of the Pancreas

Bleeding, sepsis, chest complications and other important events in the post procedure period requiring prolonged stay and /or repeat procedure

Cost effectiveness to be calculated from the average cost per patient and the number of successful outcomes.

Indian Council of Medical Research

All India Institute of Medical Sciences, New Delhi

Additional Professor

Pancreatitis, Chronic

Chronic Graft Versus Host Disease

Barbara BOURNET, MD

Cindy CANIVET

Adrian CULETTO, MD

Karl BARANGE, MD

Louis BUSCAIL, MD

Fabrice MUSCARI, MD

Charlotte MAULAT, MD

Nicolas CARRERE, MD

This study is a prospective cohort dedicated to pancreatic diseases excluding cancer. The aim is to develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies. During this study the investigators collect data and biological samples to support research project.

This collection focuses on pathology of the pancreas requiring specific investigations or management for diagnosis or treatment. Pancreatic pathologies can be classified as malignant, potentially malignant or benign tumors. These can be solid or cystic. There is an inflammatory attack on the pancreas, generating acute pancreatitis in the acute period, if the inflammatory manifestations persist, chronic pancreatitis will develop. Some lesions may be at risk of malignancy during their evolution, it is therefore necessary to improve the performance of monitoring and diagnostic tools in order to adapt the management of patients.

PAncreatic Disease Cohort of TOuLouse

To develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies

To improve the management of cystic lesions or Chronic pancreatitis on the decision of therapeutic management

Study of the microbiota of pancreatic diseases

To make available to the scientific community quality material with associated clinical data also of quality

University Hospital, Toulouse

Necrosis

Pancreatitis, Acute Necrotizing

Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy

Endoscopic management of pancreatic fluid collections

Ji Young Bang

Barbara J Broome

Ji Young Bang, MD MPH

Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.

Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.

Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.

Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. Endoscopic treatment involves the drainage of the fluid collection into the stomach or duodenum by placement of metal or plastic stents. If clinically indicated, endoscopic necrosectomy is also performed, which is the removal of devitalized pancreatic tissue using the endoscope. Currently the treatment success rate of endoscopic treatment of pancreatic fluid collections exceeds 90%.

The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.

Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.

Rate of treatment success, defined as the resolution of pancreatic fluid collection on CT scan in association with clinical resolution of symptoms at 6-months from index intervention.

Number of interventions performed to achieve treatment success

Need for any surgical intervention in patients undergoing endoscopic therapy for pancreatic fluid collections.

Technical success of endoscopic interventions in pancreatic fluid collections.

Rate of inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.

Procedure-related adverse events in patients undergoing endoscopic management of pancreatic fluid collection

Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome

Rate of hospital readmissions due to disease-related or procedure-related events in patients undergoing endoscopic therapy for pancreatic fluid collections.

Rate of disease recurrence in patients undergoing endoscopic management of pancreatic fluid collections

Rate of exocrine pancreatic insufficiency

Intervention at 4 weeks since onset of pancreatitis (traditional approach) versus intervention when the area of necrosis is contained or only partially encapsulated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laparoscopic Cystogastrostomy Versus Endoscopic Cystogastrostomy	NCT02041793	Pancreatic Pseu...	Laparoscopic cy... Endoscopic cyst...	12 Years - 80 Years	All India Institute of Medical Sciences, New Delhi
PAncreatic Disease Cohort of TOuLouse	NCT05824403	Pancreatic Dise...		18 Years -	University Hospital, Toulouse
Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections	NCT06179459	Acute Pancreati... Pancreatic Pseu... Pancreatic Necr...	Endoscopic mana...	18 Years -	Orlando Health, Inc.
PAncreatic Disease Cohort of TOuLouse	NCT05824403	Pancreatic Dise...		18 Years -	University Hospital, Toulouse

Spots Global Cancer Trial Database for acute pancreatitis