Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Rare Diseases

Necrosis

Pancreatitis

Pancreatitis, Acute Necrotizing

Pancreatic Pseudocyst

Pancreatic Diseases

Gastrointestinal Diseases

Cysts

Pancreatic Cyst

Acute Graft Versus Host Disease

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.

Orlando Health, Inc.

Pancreatitis, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

The group of participants with post-inflammatory pancreatic and peripancreatic fluid collections with double pigtail plastic stents introduced through the LAMS during endoscopic transmural drainage.

The group of participants with post-inflammatory pancreatic and peripancreatic fluid collections without double pigtail plastic stents introduced through the LAMS during endoscopic transmural drainage.

During endoscopic procedure of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections the operator introduces double pigtail plastic stents through the LAMS.

Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections

During endoscopic procedure of transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections the operator introduces transmurally the LAMS only, without the double pigtail plastic stents.

Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS only

Mateusz Jagielski, Prof.

The goal of this clinical trial is to learn about clinical usefulness of double pigtail plastic stents during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of lumen-apposing metal stents (LAMS).

The main question it aims to answer is:

Does introduction of double pigtail plastic stents through the LAMS increases efficacy and safety of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections?

Acute pancreatitis (AP) of moderate-to-severe clinical course is associated with a high risk of local complications and organ failure leading to increased mortality. Pancreatic and peripancreatic fluid collections (PPFCs) that can appear in the late phase of pancreatitis can take the form of pancreatic pseudocysts and walled-off pancreatic necrosis (WOPN). These types of PPFCs are the most common local complications of acute and chronic pancreatitis. For many years, the traditional treatment of post-inflammatory PPFCs in the late phase of pancreatitis relied on surgical methods. However, there has been a recent dynamic development of minimally invasive techniques, including endoscopic transluminal methods. While endoscopic treatment is an established method of managing these complications, some aspects of endotherapy are still a source of much controversy. One of the most debated issues in interventional endoscopy of local complications in pancreatitis is the use of transmural self-expanding metallic stents (SEMSs).

Endoscopic transmural drainage consists of creating a fistula between the lumen of the PPFC and gastrointestinal tract to allow for a free outflow of fluid out of the PPFC and into the gastrointestinal tract. During an endoscopic ultrasound (EUS)-guided procedure of endoscopic transmural drainage of post-inflammatory PPFCs, this can be visualized in the endosonographic image through the wall of the upper gastrointestinal tract. Afterwards, a transmural puncture of the PPFC is performed under EUS guidance and widened with a cystotome to a diameter of 10 Fr using coagulation. This forms a transmural cystostomy, which joins the gastrointestinal tract and the lumen of the PPFC. The next step of the endoscopic procedure is mechanical (with a dilator) or pneumatic (with a high-pressure balloon) dilation of the pancreaticocystogastrostomy or pancreaticocystoduodenostomy. Once dilated, a transmural SEMS or plastic stent(s) is introduced through the cystostomy to facilitate free passive transmural drainage of the collection contents into the gastrointestinal tract. Passive transmural drainage is an effective method of endoscopic treatment of pancreatic pseudocysts, whose contents are entirely liquid. In the case of necrotic PPFCs that contain both liquefied necrotic material and tissue fragments, it is necessary to use active transmural drainage, which consists of inserting an additional nasal drain through the transmural cystostomy to enable flushing of the collection cavity in the postoperative period.

The development of advanced endoscopic techniques has led to rapid advancements in biomedical materials, including polymers for manufacturing endoscopic devices. Currently, there is a wide variety of transmural endoprostheses of different sizes, shapes, and designs for endoscopic treatment of post-inflammatory PPFCs. These endoprostheses were divided into two groups. The first group includes plastic stents, usually made of Teflon or polyethylene. The second group is SEMSs, often referred to as "lumen-apposing metal stents" (LAMSs), that are used in the treatment of post-inflammatory pancreatic local complications. For many years, the only type of endoprosthesis available for use in transmural drainage was plastic double-pigtail stents. However, LAMSs have been attracting increasing interest as a relatively new option in endoscopy. LAMSs are a special type of SEMS used in a variety of gastrointestinal endoscopic procedures. They are made of nitinol wire and are fully covered with a silicone membrane.

However, the role of LAMSs in transmural drainage remains unclear. Many authors believe that use of LAMS during endoscopic transmural drainage increases risk of complications in form of bleeding. Despite the development of advanced endoscopic techniques and devices, the high rates of bleeding into the PPFC lumen remain a major challenge in transmural drainage treatment. This type of complication is often caused by blood vessels adjacent to the fluid collection being damaged by the distal flange of the LAMS. It seems that inserting a plastic double-pigtail stent through the LAMS limits the risk of this kind of complication by moving the back wall of the PPFC away from the distal flange, PPFC cavity bleeding during transmural drainage is still a major complication associated with a high risk of fatal outcomes.

In this trial the participants with post-inflammatory PPFCs will be divided into two arms.

The first arm will consist of participants who underwent traditional transmural drainage procedure with use of LAMS only.

The second arm will consist of participants with PPFCs who underwent endoscopic transmural drainage with use of LAMS and during the procedure double pigtail plastic stents will be introduced through the LAMS in order to prevent bleeding.

Each arm will consist of at least 50 participants with post-inflammatory PPFCs.

The Role of Double Pigtail Plastic Stents During Endoscopic Transmural Drainage of Pancreatic Fluid Collections.

The Assessment of Effectiveness and Safety of Double Pigtail Plastic Stents During Endoscopic Transmural Drainage of Post-inflammatory Pancreatic and Peripancreatic Fluid Collections With Use of Lumen-apposing Metal Stents (LAMS).

Evaluation of efficacy based on clinical picture and results of imaging examinations.

Evaluation of safety based on clinical picture and results of imaging examinations.

Evaluation of early complications within thirty days from onset of endoscopic drainage.

Evaluation of late complications of endoscopic drainage.

Assessment of clinical results of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.

Assessment of long-term results of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of double pigtail plastic stents introduced through the LAMS.

Nicolaus Copernicus University

Professor

Cholecystitis

Acalculous Cholecystitis

Cholecystitis, Acute

Gallbladder Diseases

Biliary Tract Diseases

Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent

* Ultrasonographic evaluation of the lesion by linear echoendoscope and positioning for transenteric puncture in shortest distance between enteric wall and the target lumen for drainage.
* EUS-guided transenteric puncture by using a 19-gauge needle followed by placement of a 0.035 or 0.025-inch guidewire into the target lumen.
* After the needle is removed in remaining the guidewire, the tract is dilated over the guidewire by using bougie dilator or needle type cystotome (Endoflex, Voerde, Germany). And then, the tract may be more dilated by using balloon catheter (4-mm).
* After dilation of the tract, stent delivery system is inserted over the guidewire into the target lumen.
* After complete deployment of the distal flange under EUS and fluoroscopic guidance into the target lumen, proximal retraction of the delivery system until the blue mark on the handle of the introducer is seen. And then, the proximal flange is deployed slowly under endoscopic guidance.

EUS-guided drainage

Anthony Teoh

To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB

Patients with the following conditions would be recruited for drainage under EUS guidance with the new lumen apposing FCSEMS

* Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or 10 mm)
* Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm)
* Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm)
* Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm)
* Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary approach (the diameter of the CBD \> 10 mm) (SPAXUS 8 or 10 mm)

Outcome paramaters include technical and clinical success, adverse events.

EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent

EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study

① Clinical success of pancreatic fluid collections

* Peudocyst: resolution more than 50% in the initial size of cyst.
* Walled-off necrosis: resolution of PFC without the need for additional interventions after endoscopic interventions.

- Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.

- A decrease in total bilirubin to \< 50 % of the pre-stenting value within 2 weeks.

- Satisfactory access, placement of stent and drainage.

* Bleeding: any hemorrhagic event during or after the procedure that required endotherapy, radiological interventions, blood product transfusion, or inpatient observation.

  * Perforation: perforation of the GI tract or cystic wall on imaging studies with peritonitis signs.

    * Pneumoperitoneum or pneumoretroperitoneum: intraperitoneal or retroperitoneal air on imaging study.

      * Stent migration: dislocation of the stent into the lumen or the GI tract on imaging study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections	NCT06179459	Acute Pancreati... Pancreatic Pseu... Pancreatic Necr...	Endoscopic mana...	18 Years -	Orlando Health, Inc.
The Role of Double Pigtail Plastic Stents During Endoscopic Transmural Drainage of Pancreatic Fluid Collections.	NCT06134024	Pancreatitis, A... Pancreatitis, A... Pancreatic Pseu... Pancreatic Necr... Pancreatitis, C...	Introduction of... Endoscopic tran...	18 Years -	Nicolaus Copernicus University
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent	NCT03002051	Pancreatic Pseu... Pancreatic Necr... Biliary Obstruc... Acute Cholecyst...	EUS-guided drai...	20 Years - 80 Years	Chinese University of Hong Kong

Spots Global Cancer Trial Database for pancreatic necrosis