NCT01696903

Brief Summary

Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

September 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

4.2 years

First QC Date

September 25, 2012

Last Update Submit

December 19, 2017

Conditions

Pancreatic Fistula

Keywords

Postoperative pancreatic fistulaPancreatic texturePancreatic duct diameterPancreatic consistencyPancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Clinically Relevant Postoperative Pancreatic Fistula

    Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula

    participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (1)

  • Associated postoperative morbidity

    participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Other Outcomes (1)

  • Severity of postoperative complications

    participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

Conventional anastomosis

NO INTERVENTION

Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattell's duct-to-mucosa technique".

Novel anastomosis

ACTIVE COMPARATOR

Novel anastomosis: This the active comparator to the conventional anastomosis. A new pancreaticojejunostomy technique is used for the reconstruction. The pancreas is intubated into the jejunum.

Procedure: Pancreaticojejunostomy technique

Interventions

Pancreaticojejunostomy techniquePROCEDURE

The anastomosis between jejunum and remnant pancreas has a pivotal impact on the incidence of postoperative pancreatic fistula. by this novel technique the remnant pancreas is intubated into the jejunum without extensive manipulation.

Also known as: Pancreaticojejunal anastomosis, Intubating pancreaticojejunostomy, Dunking pancreaticojejunostomy, pancreatojejunostomy
Novel anastomosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective pancreaticoduodenectomy
  • Pancreatic gland with high risk criteria for associated postoperative morbidity

You may not qualify if:

  • Patients do not accept participation
  • Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Upper Abdominal Surgery, Linköping University Hospital

Linköping, 58185, Sweden

Location

Department of Surgical gastroenterology, Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Related Publications (3)

  • Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.

    PMID: 16003309BACKGROUND

  • Ansorge C, Strommer L, Andren-Sandberg A, Lundell L, Herrington MK, Segersvard R. Structured intraoperative assessment of pancreatic gland characteristics in predicting complications after pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1076-82. doi: 10.1002/bjs.8784. Epub 2012 May 4.

    PMID: 22556164BACKGROUND

  • Kennedy EP, Yeo CJ. Dunking pancreaticojejunostomy versus duct-to-mucosa anastomosis. J Hepatobiliary Pancreat Sci. 2011 Nov;18(6):769-74. doi: 10.1007/s00534-011-0429-y.

    PMID: 21845376BACKGROUND

Related Links

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Pancreaticojejunostomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Christoph Ansorge, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Ralf Segersvärd, MD, PhD

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Christoph Ansorge, MD, PhD

Study Record Dates

First Submitted

September 25, 2012

First Posted

October 2, 2012

Study Start

September 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 20, 2017

Record last verified: 2017-12

Locations

SE(2)