One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

Pancreatic Fistula Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02511951
• Other study ID #: ahykdxdefsyy11
• Status: Recruiting
• Phase: Phase 3
• First received: July 23, 2015
• Last updated: August 16, 2015
• Start date: August 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2015
• Source: The Second Hospital of Anhui Medical University
• Contact: xiaoping geng, professor
• Phone: 86+13956010132
• Email: xp_geng[@]163.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Fistula

Intervention

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.

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Anhui Medical University	The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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 — View 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. [Epub ahead of print] — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days	Yes
Secondary	Duration of postoperative hospital stay	Time from day of operation to day of discharge	30 days	Yes
Secondary	anastomosis time	anastomosis time was calculated from begining to the end of pancreaticojejunostomy	1 hour	Yes
Secondary	reoperation rate	The secondary endpoint will be the reoperation rate	30 days	Yes
Secondary	Morbidity	the severity of complications was graded according to the Clavien-Dindo classification	30 days	Yes
Secondary	Mortality	operative mortality was defined as any death resulting from a complication during surgery	30 days	Yes
Secondary	Biliary leakage	biliary leakage was documented in line with the International Study Group of Liver Surgery(ISGLS) definitions and grading systems	30	Yes
Secondary	Blood transfusion	Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively	2 days	Yes