A Phase 3 interventional study of pancreaticojejunostomy in Pancreatic Fistula, sponsored by The Second Hospital of Anhui Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-08-18.
Sponsored by The Second Hospital of Anhui Medical University · Phase 3, Interventional, and Treatment
The aim of this study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named "One-layer duct-to-mucosa pancreaticojejunostomy" in pancreatoduodenectomy, which could provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.
Pancreaticoduodenectomy is a standard surgical approach for resectable pancreatic tumors and periampullary tumors. It is considered a safe procedure resulting from the continuous improvement in surgical techniques over the years. Although postoperative mortality has obviously decreased, pancreatic fistula is still a major challenge in pancreatic surgery and remains the major cause of postoperative morbidity and mortality after pancreaticoduodenectomy(PD), ranging from 3% to 30%.
Many risks factors have been shown to cause pancreatic fistula(PF) after the operation, including advanced age, prolonged operation time, intraoperative hemorrhage, BMI, soft pancreas, size of the main pancreatic duct and texture of the remnant pancreas. Among them, soft pancreatic texture without a dilated main pancreatic duct is regarded as the most important risk factor in predicting pancreatic fistula.
The serious consequences of pancreatic fistula result from the pancreatic juice becoming activated by the bile and intestinal fluid, which will eventually corrupt the PJ anastomosis and the surrounding normal tissues. The corrosion of the vasculature will lead to lethal hemorrhage, which is the main cause of mortality after pancreaticoduodenectomy. Furthermore, pancreatin, together with the bacteria in the alimentary tract, will lead to intra-abdominal infection and abscess. To reduce the pancreatic fistula rate, several techniques have been described as alternatives to the conventional PJ anastomosis. Duct-to-mucosa sutures, binding pancreaticojejunostomy and end-to-side invaginated fashion are widely used in the current clinical setting. Some non-randomized studies showed that the one-layer duct-to-mucosa method was a relatively safe approach. However, the prospective clinical study found that in comparison with the conventional two-layer duct-to-mucosa did obviously decrease the incidence of pancreatic fistula as well as other operative complications. The postoperative pancreatic fistula (POPF), which determines postoperative mortality, length of hospital stay， is dependent of its definition, and is reported in up to 16% of patients. The purpose of this study is to determine whether the new anastomosis called " one-layer duct-to-mucosa " pancreaticojejunostomy can reduce the POPF rate and downgrade compared with the common accepted duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following International Study Group on Pancreatic Fistula (ISGPF) criteria for pancreatic fistula (PF). The primary endpoint is the POPF rate, and others include overall postoperative complication rate and their severity reoperation rate and hospital stay.
127 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 114 is close to the median of 111 across 76 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →The Second Hospital of Anhui Medical University is the lead sponsor of 30 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
one-layer duct-to-mucosa anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.
Procedure: pancreaticojejunostomy
two-layer duct-to-mucosa anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.
Procedure: pancreaticojejunostomy
To create the posterior suturing layers, the needle is inserted from the posterior interior side of the pancreatic duct, passing through the dorsal region of the parenchyma of the pancreatic stump to the posterior surface of the pancreas approximately 0.5 cm distal to the cut edge. The other side of the needle starts from the inside of the jejunum lumen to the subserosa and then passes through the seromuscular layer to the posterior surface of the bowel.The anterior suturing layer is performed in the same manner. Two layer anatomosis with "Duct-to-Mucosa" pancreaticojejunostomy is performed by suturing the pancreatic parenchyma to the jejunal seromuscular layer and no stenting tube was used.
postoperative pancreatic fistula(POPF) rate
drainage of any measurable volume of fluid with an amylase content \>3 times the upper normal serum value on or after postoperative day 3.
Time frame: 30 days
Duration of postoperative hospital stay
Time from day of operation to day of discharge
Time frame: 30 days
anastomosis time
anastomosis time was calculated from begining to the end of pancreaticojejunostomy
Time frame: 1 hour
reoperation rate
The secondary endpoint will be the reoperation rate
Time frame: 30 days
Morbidity
the severity of complications was graded according to the Clavien-Dindo classification
Time frame: 30 days
Mortality
operative mortality was defined as any death resulting from a complication during surgery
Time frame: 30 days
Biliary leakage
biliary leakage was documented in line with the International Study Group of Liver Surgery(ISGLS) definitions and grading systems
Time frame: 30
Blood transfusion
Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively
Time frame: 2 days
The record gives a start of Aug 2015, a primary completion of Dec 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Second Hospital of Anhui Medical University