Cancer of PancreasPEAPPNCT05163977
Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy
A study testing Blumgart Anastomosis and Cattell Warren Anastomosis in people with Cancer of Pancreas, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to make a step for evaluation and presentation of a safe technique for pancreatico-jejunostomy that help in minimizing post-operative morbidity and mortality in pancreatic cancer patient by comparing Blumgart anastomosis with Cattell warren technique of anastomosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer of Pancreas
- What is being tested?
- Blumgart Anastomosis and Cattell Warren Anastomosis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jun 2021to Dec 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Known Pancreatic head cancer diagnosed radiologically.
- Operable and borderline pancreatic cancer.
- Patients who will undergo upfront surgery and those who received neoadjuvant chemotherapy are included.
Who cannot join
- Metastatic patients.
- Locally advanced cases.
- Patients with comorbidities who are unfit for major surgical procedures.
- Patients with very small pancreatic duct where the pancreatic duct can't be identified.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
The Egyptian National Cancer Institute
Cairo
About this study
Official title: Comparison Between Blumgart Anastomosis and Cattell Warren Anastomosis in Reduction of Post-Operative Complications After Pancreaticoduodenectomy Procedure
The aim of this study is to make a step for evaluation and presentation of a safe technique for pancreatico-jejunostomy that help in minimizing post-operative morbidity and mortality in pancreatic cancer patient by comparing Blumgart anastomosis with Cattell warren technique of anastomosis.
Read the detailed description
Study Design This study is a randomized prospective clinical trial. Methods of randomization: Randomized block design
The objective of the study was to evaluate the effect of Blumgart anastomosis versus Cattell Warren techniques for pancreatico-jejunostomy regarding
- Surgical technique
- Peri-operative outcome including
- Length of hospital stay
- Post-operative pancreatic fistula
- ICU admission and stay
- Operative time
- Other morbidity and mortality
Data collection:
All data will be collected for each group and will be divided into Patients' factors, intraoperative and postoperative factors. Patients' factors include patients' demographics, co-morbidities, neoadjuvant treatment, Pathology and Biliary drainage. Intra-operative factors include type of Pancreaticoduodenectomy (PD) (Whether classic or PPPD), Operative time in hours and estimated blood loss in ml, pancreatic duct and texture of pancreas. Post-operative factors include the short term post-operative course which will be divided into specific complications (pancreatic leakage, biliary leakage, delayed gastric emptying, 2ry hemorrhage, intra-abdominal collection, deep wound infection, Portal Vein (PV) - Superior Mesenteric Vein (SMV) thrombosis and general surgical complications.
- Conditions
- Cancer of Pancreas
- Being tested
- Blumgart Anastomosis, Cattell Warren Anastomosis
- Keywords
- cancer pancreas, pancreatico-jejunostomy, pancreatico-enteric anasomosis, pancreatic anastomosis, post-operative pancreatic fistula, pancreaticoduodenectomy, whipple's procedure
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blumgart AnastomosisProcedure or surgery
The anti-mesenteric border of the jejunal loop proximal to the hepatico-jejunostomy is brought against the pancreatic stump. With the pancreatic stump retracted by the stay sutures, the transected end of pancreatic duct is first identified and secured by means of a blunt tipped probe. Each trans-pancreatic, suture was performed using a single Polydioxanone (PDS) 3 -0 blunt needle. We usually take 4 sutures, 2 on each side of the duct. The process is repeated in the same manner with the remaining sutures which are tightened at the end to approximate the jejunum loop to the stump. A small stab incision is then made at the anti-mesenteric border of the jejunum and a duct to mucosa anastomosis is constructed using an interrupted 5-0 Prolene. The process is completed by placing each of the retained needles through the seromuscular layer of the anterior jejunal wall and each knot is tied over the jejunal wall which is then warped over the cut end of the stump
Cattell Warren AnastomosisProcedure or surgery
It is a two layer, interrupted, end to side pancreatico-jejunostomy. First an interrupted sutures between the posterior capsule and the seromuscular layer of the jejunum was constructed using PDS 3-0 , then a duct to mucosa interrupted sutures were taken using PDS 5-0 and finally interrupted sutures between the anterior capsule and the jejunum . The main difference here is that the sutures are taken in a conventional way which is tangential to the pancreatic capsule and parenchyma
| Study group | Role | What they receive |
|---|---|---|
| Cattell Warren Anastomosis | Active comparator | Not described Receives: Procedure: Cattell Warren Anastomosis |
| Blumgart Anastomosis | Experimental | Not described Receives: Procedure: Blumgart Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Pancreatic Fistula
We used the International Study Group of Pancreatic Fistula (ISGPF) definition which is any measurable pancreatic fluid output after postoperative day 3 (containing more than three times the normal serum amylase level; more than 300 IU/L) with clinical signs of an infection and/or necessitating a change in clinical management.
Measured: Up to 10 days after the operation
Secondary outcomes (5)
Biliary leakage
Any biliary output via percutaneous drains after the first postoperative day, or detected at a re-laparotomy
Measured: Up to 10 days after the operation
Post-Operative bleeding
including early and late bleeding (1-3 weeks post-operative) According to ISGPF it is defined as any bleeding from the surgical site with a drop in hemoglobin concentration greater than 3 g/dL with peripheral circulatory impairment requiring medical, surgical, or radiological intervention.
Measured: 1-3 weeks
Hospital Stay
the post operative hospital stay
Measured: Immediate after surgery and until the discharge of the patient ,including the readmission within the first 30 days after the operation
Operative Time
Time of the surgical procedure in hours
Measured: During the operation
primary or reactionary hemorrhage
Bleeding that occurs during or in the first day after the operation
Measured: During the operation and within the first 24 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start12 Jun 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Abdulkarim Abdulmaksoud, Cairo University
- Investigators
- Ehab A Abdulmaksoud, master, Principal investigator, National Cancer Institute Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163977
- Sponsor's protocol ID
- SO2106-31005
- Acronym
- PEAPP
- Status last verified
- Dec 2021
- First submitted
- 13 Jul 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Blumgart Anastomosis and Cattell Warren Anastomosis in Reduction of Post-Operative Complications After Pancreaticoduodenectomy Procedure
- ClinicalTrials.gov ID
- NCT05163977
- Acronym / sponsor ID
- PEAPP / SO2106-31005
- Conditions
- Cancer of Pancreas
- Keywords
- cancer pancreas, pancreatico-jejunostomy, pancreatico-enteric anasomosis, pancreatic anastomosis, post-operative pancreatic fistula, pancreaticoduodenectomy, whipple's procedure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 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.
The aim of this study is to make a step for evaluation and presentation of a safe technique for pancreatico-jejunostomy that help in minimizing post-operative morbidity and mortality in pancreatic cancer patient by comparing Blumgart anastomosis with Cattell warren technique of anastomosis.
Detailed description
Study Design This study is a randomized prospective clinical trial. Methods of randomization: Randomized block design
The objective of the study was to evaluate the effect of Blumgart anastomosis versus Cattell Warren techniques for pancreatico-jejunostomy regarding
- Surgical technique
- Peri-operative outcome including
- Length of hospital stay
- Post-operative pancreatic fistula
- ICU admission and stay
- Operative time
- Other morbidity and mortality
Data collection:
All data will be collected for each group and will be divided into Patients' factors, intraoperative and postoperative factors. Patients' factors include patients' demographics, co-morbidities, neoadjuvant treatment, Pathology and Biliary drainage. Intra-operative factors include type of Pancreaticoduodenectomy (PD) (Whether classic or PPPD), Operative time in hours and estimated blood loss in ml, pancreatic duct and texture of pancreas. Post-operative factors include the short term post-operative course which will be divided into specific complications (pancreatic leakage, biliary leakage, delayed gastric emptying, 2ry hemorrhage, intra-abdominal collection, deep wound infection, Portal Vein (PV) - Superior Mesenteric Vein (SMV) thrombosis and general surgical complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cattell Warren Anastomosis | Active comparator | Procedure: Cattell Warren Anastomosis |
| Blumgart Anastomosis | Experimental | Procedure: Blumgart Anastomosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Known Pancreatic head cancer diagnosed radiologically.
- Operable and borderline pancreatic cancer.
- Patients who will undergo upfront surgery and those who received neoadjuvant chemotherapy are included.
Key exclusion criteria (4 listed)
- Metastatic patients.
- Locally advanced cases.
- Patients with comorbidities who are unfit for major surgical procedures.
- Patients with very small pancreatic duct where the pancreatic duct can't be identified.
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 |
|---|---|---|
| Blumgart AnastomosisThe anti-mesenteric border of the jejunal loop proximal to the hepatico-jejunostomy is brought against the pancreatic stump. With the pancreatic stump retracted by the stay sutures, the transected end of pancreatic duct is first identified and secured by means of a blunt tipped probe. Each trans-pancreatic, suture was performed using a single Polydioxanone (PDS) 3 -0 blunt needle. We usually take 4 sutures, 2 on each side of the duct. The process is repeated in the same manner with the remaining sutures which are tightened at the end to approximate the jejunum loop to the stump. A small stab incision is then made at the anti-mesenteric border of the jejunum and a duct to mucosa anastomosis is constructed using an interrupted 5-0 Prolene. The process is completed by placing each of the retained needles through the seromuscular layer of the anterior jejunal wall and each knot is tied over the jejunal wall which is then warped over the cut end of the stump | Procedure or surgery | Blumgart Anastomosis |
| Cattell Warren AnastomosisIt is a two layer, interrupted, end to side pancreatico-jejunostomy. First an interrupted sutures between the posterior capsule and the seromuscular layer of the jejunum was constructed using PDS 3-0 , then a duct to mucosa interrupted sutures were taken using PDS 5-0 and finally interrupted sutures between the anterior capsule and the jejunum . The main difference here is that the sutures are taken in a conventional way which is tangential to the pancreatic capsule and parenchyma | Procedure or surgery | Cattell Warren Anastomosis |
Primary outcome
Post-Operative Pancreatic Fistula
Time frame: Up to 10 days after the operation
We used the International Study Group of Pancreatic Fistula (ISGPF) definition which is any measurable pancreatic fluid output after postoperative day 3 (containing more than three times the normal serum amylase level; more than 300 IU/L) with clinical signs of an infection and/or necessitating a change in clinical management.
5 secondary outcomes
Biliary leakage
Time frame: Up to 10 days after the operation
Post-Operative bleeding
Time frame: 1-3 weeks
Hospital Stay
Time frame: Immediate after surgery and until the discharge of the patient ,including the readmission within the first 30 days after the operation
Operative Time
Time frame: During the operation
primary or reactionary hemorrhage
Time frame: During the operation and within the first 24 hours after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Ehab A Abdulmaksoud, master principal investigator
National Cancer Institute Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blumgart Anastomosis and Cattell Warren Anastomosis in people with Cancer of Pancreas, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 4 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 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ehab A Abdulmaksoud, Master (01099192044 ext. 002, ehab.a.abdelmaksoud@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Operative Pancreatic Fistula (time frame: Up to 10 days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2021.