Clinical trial NCT03600584: Modified Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy
Official title: Modified One-layer Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Fistula
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Written Informed consent obtained；
* Both sexes between 18 and 80 years old；
* Patients scheduled to elective open pancreaticoduodenectomy.

Exclusion Criteria:

* Patients with ASA score \>=4;
* Patients who had a previous pancreatic operation;
* Patients with an immunodeficiency;
* Patients who underwent an emergency operation;
* Pregnant patients；
* Patients who was found that pancreaticoduodenectomy was not suitable。

Primary outcomes:
measure: Rate of clinically relevant postoperative pancreatic fistula (POPF)
timeFrame: Up to 60 days after Surgery
Secondary outcomes:
measure: Anastomosis time
timeFrame: intraoperatively
measure: Delayed gastric emptying
timeFrame: Up to 60 day after Surgery
measure: post-pancreatectomy hemorrhage (PPH)
timeFrame: Up to 60 days after Surgery
measure: Chyle leak
timeFrame: Up to 60 days after Surgery
measure: Overall Morbidity
timeFrame: Up to 60 days after Surgery
measure: Mortality
timeFrame: Up to 90 days after Surgery
measure: Reoperation rate
timeFrame: Up to 90 days after Surgery
measure: Readmission rate
timeFrame: Up to 60 days after Surgery
measure: Duration of postoperative hospital stay
timeFrame: Up to 90 days after Surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
Study officials:
affiliation: Nanjing Medical University
name: Miao, Prof.
role: STUDY_DIRECTOR
References:
citation: Wei J, Liu X, Wu J, Xu W, Zhou J, Lu Z, Chen J, Guo F, Gao W, Li Q, Jiang K, Dai C, Miao Y. Modified One-layer Duct-to-mucosa Pancreaticojejunostomy Reduces Pancreatic Fistula After Pancreaticoduodenectomy. Int Surg. 2015 Jun 3. doi: 10.9738/INTSURG-D-15-00094.1. Online ahead of print.
citation: Hai H, Li Z, Zhang Z, Cheng Y, Liu Z, Gong J, Deng Y. Duct-to-mucosa versus other types of pancreaticojejunostomy for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD013462. doi: 10.1002/14651858.CD013462.pub2.