Pancreaticogastrostomy Versus Pancreaticojejunostomy With Dunking Technique After Pancreaticodudenectomy: A Prospective Randomized Comparative Study

December 27, 2021 updated by: Sherif Alaa, Assiut University
To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy in the treatment of operable periampullary malignancies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreaticoduodenectomy remains the treatment of choice for periampullary malignancies. Advances in pancreatic surgery techniques and perioperative care have led to reduced mortality rates for Pancreaticodudenectomy [1]. However, morbidity after pancreatic resection remains high, with 30-60% of patients experiencing complications following surgery, mainly as a result of leak and subsequent fistula from the pancreatic anastomosis [2].The leakage of the pancreatic anastomosis remains the most serious problem as it is the major cause of morbidity after pancreaticoduodenectomy, and also contributes significantly to prolonged hospitalization [5]. For this reason, surgeons have always directed their efforts at reducing the rate of pancreatic fistula through the introduction of new and effective methods of construction of the pancreatic anastomosis [6]. Various techniques have been described for joining the pancreatic stump either with the jejunum or with the stomach, with or without internal or external drainage of the pancreatic duct. Recently, new prospective randomized studies have demonstrated the advantage of pancreaticogastrostomy over pancreaticojejunostomy in reducing the incidence of pancreatic fistula [3]; however, none of these techniques has proved to be superior in minimizing postoperative mortality and morbidity [4]. One of the difficulties of pancreatic reconstruction after pancreaticoduodenectomy is the presence of soft pancreas which leads to high risk of fistula so dunking technique was raised [8]. But few researches or papers have focused on its efficacy and even fewer papers have discussed dunking in pancreaticogastrostomy and pancreaticojejunostomy, So this is the interest of our study to compare between the efficacies of these two techniques.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All cases of resectable periampullary carcinomas

Description

Inclusion Criteria:

  • All cases of resectable periampullary carcinomas (cancer head of pancreas, ampullary carcinoma, distal cholangiocarcinoma and second part of duodenum adenocarcinoma) that are surgically fit according to ASA.

Exclusion Criteria:

  • 1. Surgically unfit cases according to ASA 2. Locally advanced irresectable cases
  • Abutment or encasement of coeliac trunk
  • Encasement of SMA less than 180 degree of its axis

  • Encasement of portal/SMV more than 180 degree of its axis or infiltration segment too long more than 2.5 cm that the remaining segment will not coapts after resection.

    3. Metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pancreaticojejunostomy
With Dunking Technique after Pancreaticodudenectomy
Procedure: Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking Technique
To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy
Pancreaticogastrostomy
With Dunking Technique after Pancreaticodudenectomy
Procedure: Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking Technique
To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of postoperative anastomosis leakage
Time Frame: One month
Compare between dunking in pancreaticogastrostomy and pancreaticojejunostomy and the rate of postoperative anastomosis leakage
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2022

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

December 27, 2021

First Posted (ACTUAL)

December 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 28, 2021

Last Update Submitted That Met QC Criteria

December 27, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pancreaticojejunostomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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