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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

Antineoplastic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Octreotide

Antineoplastic Agents, Hormonal

Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy.

Octreotide will be administered.

Re-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy.

Octreotide will be administered.

1. Trans pancreatic suture "U" stich incorporating pancreatic parenchyma and jejunal serosa, left loose.
2. Pancreatic duct to jejunal mucosa sutures, inserted and tied.
3. Trans pancreatic suture "U" stich brought back through the jejuanl serosa anteriorly, tied.

1. Posterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.
2. Pancreatic duct to jejunal mucosa sutures, inserted and tied.
3. Anterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.

Cattell-Warren Anastomosis

Octrotide (100ug) to be administered on the evening before surgery and then 100ug three times daily on the day of surgery and post operative days 1 - 6.

Christopher Halloran

The purpose of this study is to compare two different techniques of performing a pancreatic anastomosis; Cattell-Warren versus Blumgart to determine if a Blumgart anastomosis reduces pancreatic remnant leak, post-operative complications and overall length of hospital stay.

This is a randomised controlled, phase III, double blinded, multicentre clinical trial comparing Cattell-Warren (CWA) versus. Blumgart (BA) methods of pancreaticojejunostomy following pancreaticduodenectomy for supected malignancy of the pancreatic head.

The primary objective of the trial is to establish if the Blumgart anastomosis reduces pancreatic remnant leak and in turn complications, hospital stay, cost and promote enhanced recorvery programs.

506 patients (253 patients per treatment arm) will be recruited from approximately 7 centres throughout the United Kingdom.

Patients recommended for resection who provide written informed consent will be randomised to one of the following treatment arms on the day of surgery by the surgeon:

Arm A: Blumgart method of panreaticojejunostomy. Arm B: CattellWarren method pf pancreaticojejunostomy.

Randomisation will be undertaken intra-operatively, following pancreatic head excision, just prior to pancreatic head remnant reconstruction.

Patients will be assessed post operatively on days 3 to 7 and on day of dishcharge from hospital. Patients will continue to be followed up in the outpatient setting at 3, 6 and 12 months post surgery.

All laboratory and physical assessments performed will be in line standard care.

Blood samples for the translational study will be taken subject to informed consent pre-operatively and post-operatively 5 days after surgery.

A histological (H\&E stained) slide of the pancreatic transection margin should be taken as routine. This will be requested from each patient for central pathology review to assess the amount of fibrosis.

Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy

PANasta Trial Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy - a Double Blinded Multi Centred Trial

Post-operative pancreatic fistula are defined as any abnormal connection between the pancreatic duct epithelium and another epithelised surface, which contains pancreatic derived, enzyme rich fluid. This will be assessed up to 3 months following surgery on inpatient days 3-7, day of discharge (expected to be 1 - 5 weeks after surgery) and 3 month follow up.

Cancer Research UK

University of Liverpool

Consultant Pancreato-Biliary Surgeon

Fistula

Pancreatic Fistula

Pancrelipase

Pancreatin

The anti-mesenteric border of the jejunal loop proximal to the hepatico-jejunostomy is brought against the pancreatic stump. With the pancreatic stump retracted by the stay sutures, the transected end of pancreatic duct is first identified and secured by means of a blunt tipped probe. Each trans-pancreatic, suture was performed using a single Polydioxanone (PDS) 3 -0 blunt needle. We usually take 4 sutures, 2 on each side of the duct. The process is repeated in the same manner with the remaining sutures which are tightened at the end to approximate the jejunum loop to the stump. A small stab incision is then made at the anti-mesenteric border of the jejunum and a duct to mucosa anastomosis is constructed using an interrupted 5-0 Prolene. The process is completed by placing each of the retained needles through the seromuscular layer of the anterior jejunal wall and each knot is tied over the jejunal wall which is then warped over the cut end of the stump

It is a two layer, interrupted, end to side pancreatico-jejunostomy. First an interrupted sutures between the posterior capsule and the seromuscular layer of the jejunum was constructed using PDS 3-0 , then a duct to mucosa interrupted sutures were taken using PDS 5-0 and finally interrupted sutures between the anterior capsule and the jejunum . The main difference here is that the sutures are taken in a conventional way which is tangential to the pancreatic capsule and parenchyma

Cattell Warren Anastomosis

Ehab A Abdulmaksoud, Master

Haitham A Othman, MD

Ehab A Abdulmaksoud, master

The aim of this study is to make a step for evaluation and presentation of a safe technique for pancreatico-jejunostomy that help in minimizing post-operative morbidity and mortality in pancreatic cancer patient by comparing Blumgart anastomosis with Cattell warren technique of anastomosis.

Study Design This study is a randomized prospective clinical trial. Methods of randomization: Randomized block design

The objective of the study was to evaluate the effect of Blumgart anastomosis versus Cattell Warren techniques for pancreatico-jejunostomy regarding

* Surgical technique
* Peri-operative outcome including

  1. Length of hospital stay
  2. Post-operative pancreatic fistula
  3. ICU admission and stay
  4. Operative time
  5. Other morbidity and mortality

Data collection:

All data will be collected for each group and will be divided into Patients' factors, intraoperative and postoperative factors. Patients' factors include patients' demographics, co-morbidities, neoadjuvant treatment, Pathology and Biliary drainage. Intra-operative factors include type of Pancreaticoduodenectomy (PD) (Whether classic or PPPD), Operative time in hours and estimated blood loss in ml, pancreatic duct and texture of pancreas. Post-operative factors include the short term post-operative course which will be divided into specific complications (pancreatic leakage, biliary leakage, delayed gastric emptying, 2ry hemorrhage, intra-abdominal collection, deep wound infection, Portal Vein (PV) - Superior Mesenteric Vein (SMV) thrombosis and general surgical complications.

Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy

Comparison Between Blumgart Anastomosis and Cattell Warren Anastomosis in Reduction of Post-Operative Complications After Pancreaticoduodenectomy Procedure

We used the International Study Group of Pancreatic Fistula (ISGPF) definition which is any measurable pancreatic fluid output after postoperative day 3 (containing more than three times the normal serum amylase level; more than 300 IU/L) with clinical signs of an infection and/or necessitating a change in clinical management.

Any biliary output via percutaneous drains after the first postoperative day, or detected at a re-laparotomy

including early and late bleeding (1-3 weeks post-operative) According to ISGPF it is defined as any bleeding from the surgical site with a drop in hemoglobin concentration greater than 3 g/dL with peripheral circulatory impairment requiring medical, surgical, or radiological intervention.

Bleeding that occurs during or in the first day after the operation

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
Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy	NCT02457156	Pancreatic Canc...	Blumgart Anasto... Cattell-Warren ... Octreotide	18 Years -	University of Liverpool
Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy	NCT05163977	Cancer of Pancr...	Blumgart Anasto... Cattell Warren ...	-	Cairo University
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 blumgart anastomosis