An interventional study of Modified one-layer duct-to-mucosa Pancreaticojejunostomy and Invagination pancreaticojejunostomy in Pancreatic Fistula, sponsored by Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-26.
Sponsored by Nanjing Medical University · Not applicable, Interventional, and Prevention
The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy
Duct-to-mucosa and invagination pancreaticojejunostomy are two most commonly used anastomotic techniques after pancreaticoduodenectomy, with comparable incidence rate of pancreatic fistula (PF). We modified the conventional two-layer duct-to-mucosa PJ into one-layer PJ. The aim of this study is to examine if the investigator's modified duct-to-mucosa PJ can reduce PF after PD when compared to invagination PJ.
This trial is a single-center, randomized, controlled, patient- and observer- blinded study, whose primary aim is to assess whether a modified duct-to-mucosa PJ (trial group) is superior to an invagination PJ (control group), in terms of clinically relevant PF and other complications. A total of 380 patients, who are to undergo elective PD, will be recruited and randomized intraoperatively into either of the two groups. The primary efficacy endpoint is the incident rate of clinically relevant PF. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay. Patients will be followed up for 3 months. Statistical analysis will be based on the intention-to-treat population. The duration of the entire trial is estimated to be two years.
125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 380 is above the median of 110 across 75 interventional studies indexed under Pancreatic Fistula.
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Exclusion Criteria:
Modified one-layer duct-to-mucosa pancreaticojejunostomy is used after pancreaticoduodenectomy.
Procedure: Modified one-layer duct-to-mucosa Pancreaticojejunostomy
Invagination pancreaticojejunostomy is used after pancreaticoduodenectomy.
Procedure: Invagination pancreaticojejunostomy
After the completion of the preparation of the remnant pancreas for reconstruction was performed. Modified one-layer duct-to-mucosa Pancreaticojejunostomy was performed.
After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.
Rate of clinically relevant postoperative pancreatic fistula (POPF)
As defined by International Study Group on Pancreatic Fistula, a clinically relevant postoperative pancreatic fistula is now redefined as a drain output of any measurable volume of fluid with an amylase level \>3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.
Time frame: Up to 60 days after Surgery
Anastomosis time
Time from the beginning to the end of the pancreatic reconstruction
Time frame: intraoperatively
Delayed gastric emptying
The International Study Group for Pancreatic Surgery definition and classification of delayed gastric emptying were applied. Briefly, grade A, unable to tolerate solid oral intake by POD 7 and usually no vomiting; grade B, unable to tolerate solid oral intake by POD 14 with/without vomiting: and grade C, unable to tolerate solid oral intake by POD 21 with/without vomiting.
Time frame: Up to 60 day after Surgery
post-pancreatectomy hemorrhage (PPH)
The 2017 International Study Group for Pancreatic Surgery definition and classification of PPH were applied.
Time frame: Up to 60 days after Surgery
Chyle leak
The 2017 International Study Group for Pancreatic Surgery definition and classification of chyle leak were applied.
Time frame: Up to 60 days after Surgery
Overall Morbidity
Any complications that occur postoperatively. The severity of complications was graded according to the Clavien-Dindo classification.
Time frame: Up to 60 days after Surgery
Mortality
Patient death that occurs postoperatively
Time frame: Up to 90 days after Surgery
Reoperation rate
Patients who needs a surgical re-operation for any reasons during the postoperative hosptial stay. Reasons and times of reoperation are recorded.
Time frame: Up to 90 days after Surgery
Readmission rate
Patients that readmitted into hospital for reasons that related to complications of last pancreatic surgery.
Time frame: Up to 60 days after Surgery
Duration of postoperative hospital stay
Time from day of operation to day of discharge
Time frame: Up to 90 days after Surgery
Plan to share: No
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Nanjing Medical University