NCT03600584

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

July 3, 2018

Last Update Submit

July 24, 2018

Conditions

Pancreatic Fistula

Outcome Measures

Primary Outcomes (1)

  • Rate of clinically relevant postoperative pancreatic fistula (POPF)

    As defined by International Study Group on Pancreatic Fistula, a clinically relevant postoperative pancreatic fistula is now redefined as a drain output of any measurable volume of fluid with an amylase level \>3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.

    Up to 60 days after Surgery

Secondary Outcomes (9)

  • Anastomosis time

    intraoperatively

  • Delayed gastric emptying

    Up to 60 day after Surgery

  • post-pancreatectomy hemorrhage (PPH)

    Up to 60 days after Surgery

  • Chyle leak

    Up to 60 days after Surgery

  • Overall Morbidity

    Up to 60 days after Surgery

  • +4 more secondary outcomes

Study Arms (2)

One-layer duct-to-mucosa Group

EXPERIMENTAL

Modified one-layer duct-to-mucosa pancreaticojejunostomy is used after pancreaticoduodenectomy.

Procedure: Modified one-layer duct-to-mucosa Pancreaticojejunostomy

Invagination Group

ACTIVE COMPARATOR

Invagination pancreaticojejunostomy is used after pancreaticoduodenectomy.

Procedure: Invagination pancreaticojejunostomy

Interventions

Modified one-layer duct-to-mucosa PancreaticojejunostomyPROCEDURE

After the completion of the preparation of the remnant pancreas for reconstruction was performed. Modified one-layer duct-to-mucosa Pancreaticojejunostomy was performed.

One-layer duct-to-mucosa Group
Invagination pancreaticojejunostomyPROCEDURE

After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.

Invagination Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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。

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, 210029, China

Location

Related Publications (2)

  • 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.

    PMID: 26037262BACKGROUND

  • 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.

    PMID: 35289922DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Miao, Prof.

    Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Jishu Wei, M.D.

CONTACT

86-25-68136891weijishu@njmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pancreas Center

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 26, 2018

Study Start

July 1, 2018

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)