Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Anastomotic Leak

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Postoperative Complications

Pancreatic Cancer

Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Blumgart anastomosis

Blumgart Anastomosis

Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Pancreatogastric anastomosis.

Pancreatogastric anastomosis.

A national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart anastomosis).

Background: Postoperative pancreatic fistula is currently the most frequent complications after duodenopancreatectomy. There are currently no RCT comparing two of the most frequently used method of pancreato-enteric anastomosis (invaginating pancreatogastric anastomosis versus Blumgart anastomosis)

Hypothesis: in patients with resectable pancreatic and periampullary tumors, performing a Blumgart (AB) anastomosis for pancreatoenteric reconstruction after duodenopancreatectomy decreases the rate of postoperative pancreatic fistula (PPF) compared to to pancreatogastric anastomosis.

Main goal: To comparatively evaluate the rate of PPF in patients with pancreatic and periampullary tumors undergoing cephalic duodenopancreatectomy after reconstruction with Blumgart anastomosis or pancreatogastric anastomosis.

Pancreatic Anastomosis After Duodenopancreatectomy

Pancreatic Anastomosis After Duodenopancreatectomy: Pancreatogastrostomy Versus Blumgart Anastomosis: Prospective, Randomized and Multicentric Study

The post-operative pancreatic fistula (PPF) rate will be measured using the definition of the International Study Group of Pancreatic Fistula (ISGPF) : any measurable amount of fluid from a drain placed during the operation or percutaneously, with an amylase concentration greater than three times the plasma value.

According to the definition of the International Study Group on Pancreatic Surgery. which grades the severity of bleeding according to the clinical situation, diagnosis and need for treatment.

According to the definition of the International Study Group on Pancreatic Surgery, which establishes the existence of GED when a nasogastric tube is needed for more than 3 days or is placed from the third day of the postoperative period, as well as intolerance to an oral diet at the end of the first postoperative week.

According to the definition of the International Study Group of Liver Surgery, which defines it as any measurable amount of fluid from a drain placed during the operation or percutaneously, with a concentration of bilirubin greater than three times the plasma value as of the third post-operative day.

All complications that may occur during the first 90 days of the postoperative period (including the mortality rate) should be collected and classified according to the Clavien-Dindo classification and the Comprehensive Complication Index (CCI)

Instituto de Salud Carlos III

Fundación para la Investigación del Hospital Clínico de Valencia

Fistula

Pancreatic Fistula

Pathological Conditions, Anatomical

Digestive System Fistula

Biodegradable stent (polymeric prostheses) is placed from the pancreatic duct to the jejunum. Duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis.

Biodegradable stent

David Ferreras, MD

Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. The use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications.

Material and method: A single-center prospective randomized study was planned with patients undergoing PD. A duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum.

The primary outcome of the study is the evaluation of the presence of POPF (drainage fluid amylase value of \> 5000 U/L on the first day).

Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy

Usefulness of Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy. Prospective Non-randomized Controlled Clinical Study Comparing Biodegradable vs Non-biodegradable Stents

Evaluation of the presence of POPF (drainage fluid amylase value of \> 5000 U/L on the first day).

Evaluation of the position and degradation time of the biodegradable stents

Hospital Universitario Virgen de la Arrixaca

Principal Investigator

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico gasto teremino-lateral anastomosis will be performed. The anastomosis will be done with posterior wall of the stomach. Pancreas will be mobilized at least 5 cm, two tobaco stiches will be applied on posterior wall of the stomach and hole of 2 cm will be done in the middle. Anterior wall of the stomach will be opened, for easier placement of the pancreas in to the stomach cavity. Pancreas will be entered in the stomach trough , tobacco stitches tided and just 2 or 3 stitches will be applied on the stomach mucosa and pancreatic capsule. After that classic hepatico jejuno and antecolic duodeno jejuno anatomosis will ber performed.

Pancreatico gastro anastomosis

After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico jejuno termino lateral duct to mucosa anastomosis will be performed. After that classic hepatico jejuno and antecolic duodeno jejuno anatomosis will ber performed.

Pancreaticojejuno anastomosis

Dejan Radenkovic, MD, PhD

Dejan Radenkovic, MD,PhD

Pancreaticoduodenectomy is the standards surgical procedure for various malignant and benign disease of the pancreas and periampullariy region. During the recent years, mortality rate of pancreaticoduodenectomy has decreased to 5% in specialized centers. Although, this procedure still carries considerable morbidity up to 40%, depending of definition of complications. Pancreatic fistula remains a common complication and the main cause of other morbidities and mortality. Pancreaticojejunal (PJ) anastomosis is the most often used method of reconstruction after pancreaticoduodenectomy. Several technique modifications such as placement of the stents, reinforcement of anasomosis with fibrin glue, pancreatic duct occlusion and pancreaticogastrostomy (PG) type of anastomosis was used in order to decrease pancreatic fistula rate. Since, some retrospective studies showed better results with some technique, several meta-analyses did not show any advantage of those various modifications. It was shown that the higher risk of pancreatic fistula was noticed in patients with soft residual pancreas and small diameter of pancreatic duct. There is only one randomized study in the literature dealing with this problem. This study did not reveal any significant differences between PG and PJ in patients with soft pancreas and small duct. In order to investigate once more this important issue, the researchers conducted randomized multicenter controlled trial.

Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy

Results of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy in Patients With Soft Pancreas and Small Pancreatic Duct

Abdominal complications comprises: Pancreatic fistula, acute fluid collection, acute pancreatitis, billiay fistula, gastric fistula, enteral distula, hemorrhage and delayed gastric emptying

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pancreatic Anastomosis After Duodenopancreatectomy	NCT04462354	Pancreatic Anas... Pancreatic Neop...	Blumgart Anasto... Pancreatogastri...	18 Years -	Fundación para la Investigación del Hospital Clínico de Valencia
Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy	NCT04783831	Pancreatic Fist... Pancreas Neopla... Stent Disintegr... Pancreatic Canc... Pancreatic Anas...	Biodegradable s...	18 Years -	Hospital Universitario Virgen de la Arrixaca
Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy	NCT01324856	Pancreatic Canc... Pancreatic Anas...	Pancreatico gas... Pancreaticojeju...	18 Years - 80 Years	University of Belgrade
Pancreatic Anastomosis After Duodenopancreatectomy	NCT04462354	Pancreatic Anas... Pancreatic Neop...	Blumgart Anasto... Pancreatogastri...	18 Years -	Fundación para la Investigación del Hospital Clínico de Valencia

Spots Global Cancer Trial Database for pancreatic anastomotic leak