Periampullary CarcinomaNCT04387903
Reoperation After Pancreaticoduodenectomy
An observational study of Periampullary Carcinoma and Pancreatic Cancer, run by Mansoura University.
Trial summary
The aim of this study is to outline the incidence of early and late reoperation after PD, examine the risk factors for early surgical intervention and its impact on the surgical outcome, hospital stay, diseases recurrence and patient survival, address variable indications for late readmission and reoperation after PD… Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Periampullary Carcinoma, Pancreatic Cancer
- What is being tested?
- Surgical re-interventionafter pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 1 Aug 2020
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a retrospective cohort study of all patients who underwent PD for periampullary malignant lesions in the duration between January 2000 and May 2018. Preoperative assessment was performed by clinical examination and detailed laboratory investigations. Assessment of local extension of the tumor and metastatic work-up was performed by pelvi-abdominal ultrasound (US), triphasic abdominal computerized tomography (CT) with angiographic assessment of the surrounding vessels, bone survey, and chest X-ray. Preoperative endoscopic retrograde cholangiopancreatography (ERCP) for preoperative biliary drainage was performed in selected cases
Who may be able to join
- all patients who underwent pancreaticoduodenectomy for periampullary malignant lesions in the duration between January 2000 and May 2018
Who cannot join
- Pancreaticoduodenectomy performed for benign tumors, recurrent malignant tumors, chronic pancreatitis, or inflammatory strictures were excluded from the study.
About this study
Official title: Surgical Intervention After Pancreaticoduodenectomy: Incidence, Indications, Risk Factors and Outcome
The aim of this study is to outline the incidence of early and late reoperation after PD, examine the risk factors for early surgical intervention and its impact on the surgical outcome, hospital stay, diseases recurrence and patient survival, address variable indications for late readmission and reoperation after PD and its impact on patient survival and disease recurrence.
Read the detailed description
This is a retrospective cohort study of all patients who underwent PD for periampullary tumors in Gastrointestinal Surgical Center (GISC), Mansoura University, Egypt in the period between 2000 and 2018.The exclusion criteria included any patients with locally advanced periampullary tumor, metastases, patients with advanced liver cirrhosis (Child B or C), malnutrition, or coagulopathy.
Patient data were recorded in a prospectively maintained database. Preoperative variables included; age, sex, body mass index, patients' symptoms and signs, laboratory tests, tumor markers and preoperative biliary drainage. Intraoperative variables included; liver status, tumor size, pancreatic duct diameter, texture of the pancreas, operative time, blood loss, pancreatic reconstruction method and blood transfusion. Postoperative variables included postoperative complications, drain amylase, liver function, day to resume oral feeding, postoperative stay, re-exploration, hospital mortality, postoperative pathology, and surgical safety margins.
Data regarding reoperation included incidence, male to female ratio, hospital stay, interval to reoperation, number of explorations, indication of reoperation and surgical management, and postoperative outcome in terms of morbidity and hospital stay. Follow-up was carried out one week postoperatively, 3 months, 6 months and then after one year. The minimum duration of follow up was 2 years. Follow up was done by thorough history taking, clinical examination and abdominal CT in case of suspicious lesions on pelvi-abdominal ultrasound.
- Conditions
- Periampullary Carcinoma, Pancreatic Cancer
- Being tested
- Surgical re-interventionafter pancreaticoduodenectomy
- Keywords
- Pancreaticoduodenectomy, pancreatic fistula, pancreatic cancer, reoperation
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical re-interventionafter pancreaticoduodenectomyProcedure or surgery
Mandatory surgical management of complications after pancreatico-duodenectomy through peritoneal lavage, draiange, repair of fistula, completion pancreatectomy, control of bleeding, bowel resection, and feeding jejunostomy.
| Study group | Role | What they receive |
|---|---|---|
| Reoperation group | The group of patients who underwent pancreaticduodenectomy for management of periampullary tumors and required surgical reintervention afterwards for management of procedure-related complications as pancreatic fistula, bleeding, abdominal collection, biliary fistula, gastric fistula. Receives: Procedure: Surgical re-interventionafter pancreaticoduodenectomy | |
| No reoperation group | The group of patients who underwent pancreaticoduodenectomy for management of periampullary tumors and did not require surgical reintervention. Receives: Procedure: Surgical re-interventionafter pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
The duration between surgical intervention to patient death
Measured: 2-20 years after surgery
Tumor recurrence
Duration between surgery and recurrence of periampullary tumors based on radiological or endoscopic investigations.
Measured: 2-20 years
Secondary outcomes (3)
Hospital stay after reoperation
duration between reoperation surgery to discharge from hospital
Measured: 10-90 days after reoperation
Morbidity after reoperation
complications after reoperation including intr- or extra-luminal hemorrhage, pancreatic or gastric fistula, biliary leakage, thromboembolic diseases, and wound infection
Measured: 10-90 days after reoperation
Risk factors for surgical reoperation
Factors that increase the probability that the patient undergoing pancreaticoduodenectomy would be at higher risk for reoperation
Measured: Before surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Jan 2000
- Primary completion1 May 2018
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periampullary CarcinomaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Hamed, Mansoura University
- Investigators
- Ayman El Nakeeb, md, Study director, Professor of Surgery, Gastrointestinal Surgical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387903
- Sponsor's protocol ID
- R.20.04.819
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be prepared as a research paper and the cohort results will be published in a scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Intervention After Pancreaticoduodenectomy: Incidence, Indications, Risk Factors and Outcome
- ClinicalTrials.gov ID
- NCT04387903
- Acronym / sponsor ID
- R.20.04.819
- Conditions
- Periampullary Carcinoma, Pancreatic Cancer
- Keywords
- Pancreaticoduodenectomy, pancreatic fistula, pancreatic cancer, reoperation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 14 May 2020 (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 outline the incidence of early and late reoperation after PD, examine the risk factors for early surgical intervention and its impact on the surgical outcome, hospital stay, diseases recurrence and patient survival, address variable indications for late readmission and reoperation after PD and its impact on patient survival and disease recurrence.
Detailed description
This is a retrospective cohort study of all patients who underwent PD for periampullary tumors in Gastrointestinal Surgical Center (GISC), Mansoura University, Egypt in the period between 2000 and 2018.The exclusion criteria included any patients with locally advanced periampullary tumor, metastases, patients with advanced liver cirrhosis (Child B or C), malnutrition, or coagulopathy.
Patient data were recorded in a prospectively maintained database. Preoperative variables included; age, sex, body mass index, patients' symptoms and signs, laboratory tests, tumor markers and preoperative biliary drainage. Intraoperative variables included; liver status, tumor size, pancreatic duct diameter, texture of the pancreas, operative time, blood loss, pancreatic reconstruction method and blood transfusion. Postoperative variables included postoperative complications, drain amylase, liver function, day to resume oral feeding, postoperative stay, re-exploration, hospital mortality, postoperative pathology, and surgical safety margins.
Data regarding reoperation included incidence, male to female ratio, hospital stay, interval to reoperation, number of explorations, indication of reoperation and surgical management, and postoperative outcome in terms of morbidity and hospital stay. Follow-up was carried out one week postoperatively, 3 months, 6 months and then after one year. The minimum duration of follow up was 2 years. Follow up was done by thorough history taking, clinical examination and abdominal CT in case of suspicious lesions on pelvi-abdominal ultrasound.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reoperation group | – | Procedure: Surgical re-interventionafter pancreaticoduodenectomyThe group of patients who underwent pancreaticduodenectomy for management of periampullary tumors and required surgical reintervention afterwards for management of procedure-related complications as pancreatic fistula, bleeding, abdominal collection, biliary fistula, gastric fistula. |
| No reoperation group | – | Procedure: Surgical re-interventionafter pancreaticoduodenectomyThe group of patients who underwent pancreaticoduodenectomy for management of periampullary tumors and did not require surgical reintervention. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a retrospective cohort study of all patients who underwent PD for periampullary malignant lesions in the duration between January 2000 and May 2018. Preoperative assessment was performed by clinical examination and detailed laboratory investigations. Assessment of local extension of the tumor and metastatic work-up was performed by pelvi-abdominal ultrasound (US), triphasic abdominal computerized tomography (CT) with angiographic assessment of the surrounding vessels, bone survey, and chest X-ray. Preoperative endoscopic retrograde cholangiopancreatography (ERCP) for preoperative biliary drainage was performed in selected cases
Key inclusion criteria (1 listed)
- all patients who underwent pancreaticoduodenectomy for periampullary malignant lesions in the duration between January 2000 and May 2018
Key exclusion criteria (1 listed)
- Pancreaticoduodenectomy performed for benign tumors, recurrent malignant tumors, chronic pancreatitis, or inflammatory strictures were excluded from the study.
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 |
|---|---|---|
| Surgical re-interventionafter pancreaticoduodenectomyMandatory surgical management of complications after pancreatico-duodenectomy through peritoneal lavage, draiange, repair of fistula, completion pancreatectomy, control of bleeding, bowel resection, and feeding jejunostomy. | Procedure or surgery | No reoperation group, Reoperation group |
Primary outcome
Patient survival
Time frame: 2-20 years after surgery
The duration between surgical intervention to patient death
Tumor recurrence
Time frame: 2-20 years
Duration between surgery and recurrence of periampullary tumors based on radiological or endoscopic investigations.
3 secondary outcomes
Hospital stay after reoperation
Time frame: 10-90 days after reoperation
Morbidity after reoperation
Time frame: 10-90 days after reoperation
Risk factors for surgical reoperation
Time frame: Before surgical intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: No. The data will be prepared as a research paper and the cohort results will be published in a scientific journal.
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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.
Ayman El Nakeeb, md study director
Professor of Surgery, Gastrointestinal Surgical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Periampullary Carcinoma and Pancreatic Cancer, run by Mansoura 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 1 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 14 May 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival (time frame: 2-20 years after surgery). The study lists 2 primary outcomes in all. 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 14 May 2020.