Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University
ClinicalTrials.gov Identifier:
NCT01731821
First received: November 10, 2012
Last updated: November 17, 2012
Last verified: November 2012
  Purpose

Pancreaticojejunostomy is the key procedure of pancreaticoduodenectomy. The aim of our study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named "nonstented stump-closed pancreaticojejunostomy" in pancreatoduodenectomy, which could provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.


Condition Intervention Phase
Pancreatic Neoplasms
Biliary Tract Neoplasms
Pancreatitis, Chronic
Duodenal Neoplasms
Procedure: pancreaticojejunostomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy: Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • the postoperative pancreatic fistula(POPF) rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • postoperative hospital stay time; [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • anastomosis time; [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • reoperation rate; [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • morbidity and mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 308
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nonstented stump-closed anastomosis
Nonstented stump-closed anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.
Procedure: pancreaticojejunostomy

Nonstented stump closed pancreaticojejunostomy:

Close the pancreatic stump with interrupted inverting sutures around the "papillary-like" pancreatic duct.

A small full-thickness enterotomy was penetrated on the jejunal wall for connecting to the "papillary-like" pancreatic duct by placing 4-6 sutures from the "periductal" parenchyma to the whole-layer jejunum hole. After that, interrupted sutures between the front wall of pancreatic stump and the seromuscular jejunum were performed by 4-0 absorbable sutures to complete the anastomosis.

Duct-to-mucosa pancreaticojejunostomy: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.

Active Comparator: Duct-to-mucosa anastomosis
Duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy.
Procedure: pancreaticojejunostomy

Nonstented stump closed pancreaticojejunostomy:

Close the pancreatic stump with interrupted inverting sutures around the "papillary-like" pancreatic duct.

A small full-thickness enterotomy was penetrated on the jejunal wall for connecting to the "papillary-like" pancreatic duct by placing 4-6 sutures from the "periductal" parenchyma to the whole-layer jejunum hole. After that, interrupted sutures between the front wall of pancreatic stump and the seromuscular jejunum were performed by 4-0 absorbable sutures to complete the anastomosis.

Duct-to-mucosa pancreaticojejunostomy: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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • 18-80 years old;
  • Eastern Cooperative Oncology Group(ECOG) 0-2
  • Patients must have undergone pancreaticoduodenectomy.
  • Preoperative enhanced CT scan shows respectable or borderline resectable neoplasm
  • Without distal metastasis

Exclusion Criteria:

  • Patients who have had previous pancreatic body tail resection rese
  • immunodeficiency, people infected with HIV
  • patients with severe cardiopulmonary function, liver and renal function
  • infection without control or active infections
  • Pregnant patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731821

Contacts
Contact: Xian-Jun Yu, M.D. +86 21 64175590 ext 1305 yuxianjun88@hotmail.com

Locations
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Chen Liu, M.D.    +86 21 64175590 ext 1305    blurlc@hotmail.com   
Principal Investigator: Xian-Jun Yu, M.D.         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Xian-Jun Yu, M.D. Department of Pancreatic & Hepatobiliary Surgery
  More Information

No publications provided

Responsible Party: Xian-Jun Yu, Professor and Chair,Department of Pancreatic & Hepatobiliary Surgery, Fudan University
ClinicalTrials.gov Identifier: NCT01731821     History of Changes
Other Study ID Numbers: PCI001
Study First Received: November 10, 2012
Last Updated: November 17, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Pancreaticoduodenectomy
Pancreaticojejunostomy

Additional relevant MeSH terms:
Duodenal Diseases
Biliary Tract Neoplasms
Neoplasms
Duodenal Neoplasms
Pancreatic Neoplasms
Pancreatitis
Pancreatitis, Chronic
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014