NCT01731821

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

November 10, 2012

Last Update Submit

December 2, 2014

Conditions

Pancreatic NeoplasmsBiliary Tract NeoplasmsPancreatitis, ChronicDuodenal Neoplasms

Keywords

PancreaticoduodenectomyPancreaticojejunostomy

Outcome Measures

Primary Outcomes (1)

  • the postoperative pancreatic fistula(POPF) rate

    30 days

Secondary Outcomes (4)

  • postoperative hospital stay time;

    90 days

  • anastomosis time;

    1 hour

  • reoperation rate;

    30 days

  • morbidity and mortality

    90 days

Study Arms (2)

Nonstented stump-closed anastomosis

EXPERIMENTAL

Nonstented stump-closed anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.

Procedure: pancreaticojejunostomy

Duct-to-mucosa anastomosis

ACTIVE COMPARATOR

Duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy.

Procedure: pancreaticojejunostomy

Interventions

pancreaticojejunostomyPROCEDURE

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.

Duct-to-mucosa anastomosisNonstented stump-closed anastomosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Xu J, Zhang B, Shi S, Qin Y, Ji S, Xu W, Liu J, Liu L, Liu C, Long J, Ni Q, Yu X. Papillary-like main pancreatic duct invaginated pancreaticojejunostomy versus duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: A prospective randomized trial. Surgery. 2015 Nov;158(5):1211-8. doi: 10.1016/j.surg.2015.04.020. Epub 2015 May 30.

    PMID: 26036878DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsBiliary Tract NeoplasmsPancreatitis, ChronicDuodenal Neoplasms

Interventions

Pancreaticojejunostomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesDuodenal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Xian-Jun Yu, M.D.

    Department of Pancreatic & Hepatobiliary Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair,Department of Pancreatic & Hepatobiliary Surgery

Study Record Dates

First Submitted

November 10, 2012

First Posted

November 22, 2012

Study Start

October 1, 2012

Primary Completion

June 1, 2014

Study Completion

October 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

CN(1)