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Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

NCT ID: NCT01696903

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.

Conditions

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Pancreatic Fistula

Keywords

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Postoperative pancreatic fistula Pancreatic texture Pancreatic duct diameter Pancreatic consistency Pancreaticoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional anastomosis

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Novel anastomosis

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.

Group Type ACTIVE_COMPARATOR

Pancreaticojejunostomy technique

Intervention Type PROCEDURE

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.

Interventions

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Pancreaticojejunostomy technique

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.

Intervention Type PROCEDURE

Other Intervention Names

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Pancreaticojejunal anastomosis Intubating pancreaticojejunostomy Dunking pancreaticojejunostomy pancreatojejunostomy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Christoph Ansorge

Christoph Ansorge, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph Ansorge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Ralf Segersvärd, MD, PhD

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

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Department of Upper Abdominal Surgery, Linköping University Hospital

Linköping, , Sweden

Site Status

Department of Surgical gastroenterology, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 16003309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22556164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21845376 (View on PubMed)

Related Links

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http://ki.se

Issuer organization

http://www.karolinska.se

Investigation site

http://www.lio.se

Investigation site

Other Identifiers

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KI-DSGE-DUAS

Identifier Type: OTHER

Identifier Source: secondary_id

SKARV-GLH-001

Identifier Type: -

Identifier Source: org_study_id