Clinical trial NCT02511951: One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy
Official title: A Prospective Randomized Clinical Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy: One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Fistula
Keywords: postoperative pancreatic fistula
postoperative hospital stay time
anastomosis time
reoperation rate
morbidity
pancreaticojejunostomy
pancreaticoduodenectomy
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui Medical University
First posted: 2015-07-30
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Both male and female, aged 18 to 80;
* Patients scheduled to undergo pancreaticoduodenectomy;
* Provided written informed consent;

Exclusion criteria:

* Patients with severe cardiopulmonary disorder that might prolong the postoperative hospital stay;
* Patients who had a previous pancreatic operation;
* Patients with an immunodeficiency;
* Patients who underwent an emergency operation;
* Pregnant patients.

Primary outcomes:
measure: postoperative pancreatic fistula(POPF) rate
timeFrame: 30 days
Secondary outcomes:
measure: Duration of postoperative hospital stay
timeFrame: 30 days
measure: anastomosis time
timeFrame: 1 hour
measure: reoperation rate
timeFrame: 30 days
measure: Morbidity
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Biliary leakage
timeFrame: 30
measure: Blood transfusion
timeFrame: 2 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: the Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: the vice President of the second affiliated hospitalof Anhui medical university
name: xiaoping geng, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang L, Li Z, Wu X, Li Y, Zeng Z. Sealing pancreaticojejunostomy in combination with duct parenchyma to mucosa seromuscular one-layer anastomosis: a novel technique to prevent pancreatic fistula after pancreaticoduodenectomy. J Am Coll Surg. 2015 May;220(5):e71-7. doi: 10.1016/j.jamcollsurg.2014.12.047. Epub 2015 Jan 15. No abstract available.
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: El Nakeeb A, El Hemaly M, Askr W, Abd Ellatif M, Hamed H, Elghawalby A, Attia M, Abdallah T, Abd ElWahab M. Comparative study between duct to mucosa and invagination pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized study. Int J Surg. 2015 Apr;16(Pt A):1-6. doi: 10.1016/j.ijsu.2015.02.002. Epub 2015 Feb 13.
citation: Pan SB, Geng W, Zhou DC, Chen JM, Zhao HC, Liu FB, Xie SX, Hou H, Zhao YJ, Xie K, Wang GB, Geng XP. One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial. Trials. 2016 Aug 17;17(1):407. doi: 10.1186/s13063-016-1517-8.