Pancreaticobiliary CancerNCT05171361
Pancreaticogastrostomy Versus Pancreaticojejunostomy With Dunking Technique After Pancreaticodudenectomy: A Prospective Randomized Comparative Study
An observational study of Pancreaticobiliary Cancer, run by Assiut University.
Trial summary
To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy in the treatment of operable periampullary malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreaticobiliary Cancer
- What is being tested?
- Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking Technique
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All cases of resectable periampullary carcinomas
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy in the treatment of operable periampullary malignancies.
Read the 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.
- Conditions
- Pancreaticobiliary Cancer
- Being tested
- Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking Technique
- Keywords
- pancreaticojejunostomy, pancreaticogastrostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking TechniqueProcedure or surgery
To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy
| Study group | Role | What they receive |
|---|---|---|
| Pancreaticojejunostomy | With Dunking Technique after Pancreaticodudenectomy Receives: Procedure: Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking Technique | |
| Pancreaticogastrostomy | With Dunking Technique after Pancreaticodudenectomy Receives: Procedure: Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative anastomosis leakage
Compare between dunking in pancreaticogastrostomy and pancreaticojejunostomy and the rate of postoperative anastomosis leakage
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study startMar 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreaticobiliary CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Alaa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171361
- Sponsor's protocol ID
- Pancreaticojejunostomy
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng Y, Briarava M, Lai M, Wang X, Tu B, Cheng N, Gong J, Yuan Y, Pilati P, Mocellin S. Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD012257. doi: 10.1002/14651858.CD012257.pub2.
PubMed 28898386Que W, Fang H, Yan B, Li J, Guo W, Zhai W, Zhang S. Pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy: a meta-analysis of randomized controlled trials. Am J Surg. 2015 Jun;209(6):1074-82. doi: 10.1016/j.amjsurg.2014.07.019. Epub 2015 Jan 22.
PubMed 25743406
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreaticogastrostomy Versus Pancreaticojejunostomy With Dunking Technique After Pancreaticodudenectomy: A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05171361
- Acronym / sponsor ID
- Pancreaticojejunostomy
- Conditions
- Pancreaticobiliary Cancer
- Keywords
- pancreaticojejunostomy, pancreaticogastrostomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy in the treatment of operable periampullary malignancies.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreaticojejunostomy | – | Procedure: Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking TechniqueWith Dunking Technique after Pancreaticodudenectomy |
| Pancreaticogastrostomy | – | Procedure: Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking TechniqueWith Dunking Technique after Pancreaticodudenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases of resectable periampullary carcinomas
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking TechniqueTo compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy | Procedure or surgery | Pancreaticogastrostomy, Pancreaticojejunostomy |
Primary outcome
Rate of postoperative anastomosis leakage
Time frame: One month
Compare between dunking in pancreaticogastrostomy and pancreaticojejunostomy and the rate of postoperative anastomosis leakage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Background: PubMed 28898386Cheng Y, Briarava M, Lai M, Wang X, Tu B, Cheng N, Gong J, Yuan Y, Pilati P, Mocellin S. Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD012257. doi: 10.1002/14651858.CD012257.pub2.
- Background: PubMed 25743406Que W, Fang H, Yan B, Li J, Guo W, Zhai W, Zhang S. Pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy: a meta-analysis of randomized controlled trials. Am J Surg. 2015 Jun;209(6):1074-82. doi: 10.1016/j.amjsurg.2014.07.019. Epub 2015 Jan 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreaticobiliary Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif Alaa Abdelhafez, Resident (00201004884894, sherifabdelhafez94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative anastomosis leakage (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05171361, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.