Pancreas CancerNCT05192044
Less Than 100 Hours Hospital Stay After Pancreatico-duodenectomy, RCT
A study testing Fast track Care pancreatico-duodenectomy. and Conventional Care in people with Pancreas Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Few decades back pancreatico-duodenectomy (PD) was associated with a very high morbidity and mortality. With recent advancements in surgical and anesthetic techniques and improvement in peri-operative care, PD has evolved into a procedure with acceptable morbidity and mortality. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Fast track Care pancreatico-duodenectomy. and Conventional Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2021to 1 Jul 2023
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≤ 75 years
- ASA 1 or 2
- BMI < 35
- The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study
Who cannot join
- pancreatico-duodenectomy with vascular reconstruction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, 11796
Ahmed M Mahmoud, Professor, 01001729571 ext. +2, drbarbary@yahoo.com
About this study
Few decades back pancreatico-duodenectomy (PD) was associated with a very high morbidity and mortality. With recent advancements in surgical and anesthetic techniques and improvement in peri-operative care, PD has evolved into a procedure with acceptable morbidity and mortality. Today PD is associated with a mortality of less than 5%, in high volume tertiary care centers. The multimodal concept of fast-track surgery was first introduced in colonic surgery. Several studies have demonstrated the effectiveness of this program in colonic resection. Recently, fast-track surgery has been attempted in pancreatic surgery with encouraging results, but such data are sparse. The core aims of ERAS protocols are to safely hasten postoperative recovery and ease the stress response.
Specifically, in the context of pancreatico-duodenectomy, such interventions have been shown to be safe with no increase in mortality or unplanned readmissions, delayed gastric emptying (DGE), or pancreatic fistula . Purported benefits include reduced admission related costs, incidence of DGE, overall morbidity and length of stay.
The aim of this study was to evaluate the feasibility of implementing fast track rehabilitation protocol following pancreaticoduodenectomy and to see if it is associated with improved recovery, reduced morbidity and reduced length of hospital stay.
Read the detailed description
Study population: This is a prospective study that will be conducted on all patients of both sexes and definite age groups attending the National Cancer Institute, Cairo University and candidate for pancreatico-duodenectomy Sampling: all cases fulfilling the inclusion criteria will be included in the study.
Patients will be classified into two groups:
- Group A: Fast track Care pancreatico-duodenectomy.
- Group B: Conventional Care pancreatico-duodenectomy. Baseline demographics, body mass index (BMI), perioperative parameters, postoperative course, postoperative complications and 30-days operative mortality will be analyzed.
Inclusion criteria:
- Age ≤ 75 years
- ASA 1 or 2
- BMI < 35 The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study
Exclusion criteria:
- pancreatico-duodenectomy with vascular reconstruction.
- Unenthusiastic patients.
Type of study: randomized controlled trial The assignment of patients to either group will be done by a random computer-assissted allocation. The allocation will be done by the use of opaque envelopes with assignments.
It's an open-labeled study i.e. patients, investigators (surgeons, researchers) and data collectors will know which procedure will be done to which patients.
Discharge criteria for goup A include; uncomplicated procedure, afebrile patient without tachycardia, tolerance of oral feeding, adequate control of pain with oral analgesia, patient ambulating independently, adequate support at home.
Follow up: will be completed within one month (immediate post-operative outcome).
- Conditions
- Pancreas Cancer
- Being tested
- Fast track Care pancreatico-duodenectomy., Conventional Care
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast track Care pancreatico-duodenectomy.Other
Enhanced recovery after pancreatico-duodenectomy, with early oral intake, mobilization \& discharge
Conventional CareOther
Conventional Care
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Fast track Care (Enhanced recovery after)pancreatico-duodenectomy Receives: Other: Fast track Care pancreatico-duodenectomy. |
| Group B | Active comparator | Conventional Care pancreatico-duodenectomy. Receives: Other: Conventional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of enhanced recovery after pancreatico-dudenectomy
Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start25 Dec 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Mahmoud, Professor, Study director, National Cancer Institute, Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192044
- Sponsor's protocol ID
- Debakey4
- Status last verified
- Dec 2021
- First submitted
- 30 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In a publication
Publications
Debakey Y, Mostafa MS, Refaat A, Sheier SS, Nofal A. ERAS enables safe </= 100-hour discharge after pancreatoduodenectomy: a multicenter cohort study. Langenbecks Arch Surg. 2026 Jun 26;411(1):172. doi: 10.1007/s00423-026-04088-1.
PubMed 42360327
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Less Than 100 Hours Hospital Stay After Pancreatico-duodenectomy, RCT
- ClinicalTrials.gov ID
- NCT05192044
- Acronym / sponsor ID
- Debakey4
- Conditions
- Pancreas Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 14 Jan 2022 (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.
Few decades back pancreatico-duodenectomy (PD) was associated with a very high morbidity and mortality. With recent advancements in surgical and anesthetic techniques and improvement in peri-operative care, PD has evolved into a procedure with acceptable morbidity and mortality. Today PD is associated with a mortality of less than 5%, in high volume tertiary care centers. The multimodal concept of fast-track surgery was first introduced in colonic surgery. Several studies have demonstrated the effectiveness of this program in colonic resection. Recently, fast-track surgery has been attempted in pancreatic surgery with encouraging results, but such data are sparse. The core aims of ERAS protocols are to safely hasten postoperative recovery and ease the stress response.
Specifically, in the context of pancreatico-duodenectomy, such interventions have been shown to be safe with no increase in mortality or unplanned readmissions, delayed gastric emptying (DGE), or pancreatic fistula . Purported benefits include reduced admission related costs, incidence of DGE, overall morbidity and length of stay.
The aim of this study was to evaluate the feasibility of implementing fast track rehabilitation protocol following pancreaticoduodenectomy and to see if it is associated with improved recovery, reduced morbidity and reduced length of hospital stay.
Detailed description
Study population: This is a prospective study that will be conducted on all patients of both sexes and definite age groups attending the National Cancer Institute, Cairo University and candidate for pancreatico-duodenectomy Sampling: all cases fulfilling the inclusion criteria will be included in the study.
Patients will be classified into two groups:
- Group A: Fast track Care pancreatico-duodenectomy.
- Group B: Conventional Care pancreatico-duodenectomy. Baseline demographics, body mass index (BMI), perioperative parameters, postoperative course, postoperative complications and 30-days operative mortality will be analyzed.
Inclusion criteria:
- Age ≤ 75 years
- ASA 1 or 2
- BMI < 35 The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study
Exclusion criteria:
- pancreatico-duodenectomy with vascular reconstruction.
- Unenthusiastic patients.
Type of study: randomized controlled trial The assignment of patients to either group will be done by a random computer-assissted allocation. The allocation will be done by the use of opaque envelopes with assignments.
It's an open-labeled study i.e. patients, investigators (surgeons, researchers) and data collectors will know which procedure will be done to which patients.
Discharge criteria for goup A include; uncomplicated procedure, afebrile patient without tachycardia, tolerance of oral feeding, adequate control of pain with oral analgesia, patient ambulating independently, adequate support at home.
Follow up: will be completed within one month (immediate post-operative outcome).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Fast track Care pancreatico-duodenectomy.Fast track Care (Enhanced recovery after)pancreatico-duodenectomy |
| Group B | Active comparator | Other: Conventional CareConventional Care pancreatico-duodenectomy. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≤ 75 years
- ASA 1 or 2
- BMI < 35
- The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study
Key exclusion criteria (1 listed)
- pancreatico-duodenectomy with vascular reconstruction.
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 |
|---|---|---|
| Fast track Care pancreatico-duodenectomy.Enhanced recovery after pancreatico-duodenectomy, with early oral intake, mobilization \& discharge | Other | Group A |
| Conventional CareConventional Care | Other | Group B |
Primary outcome
Feasibility of enhanced recovery after pancreatico-dudenectomy
Time frame: 1 month after surgery
Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Derived from this study: PubMed 42360327Debakey Y, Mostafa MS, Refaat A, Sheier SS, Nofal A. ERAS enables safe </= 100-hour discharge after pancreatoduodenectomy: a multicenter cohort study. Langenbecks Arch Surg. 2026 Jun 26;411(1):172. doi: 10.1007/s00423-026-04088-1.
- Individual participant dataSharing planned: Yes. In a publication
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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.
Ahmed M Mahmoud, Professor study director
National Cancer Institute, Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast track Care pancreatico-duodenectomy. and Conventional Care in people with Pancreas Cancer, run by National Cancer Institute, Egypt 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 4 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 Jan 2022. 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 Yasser A Debakey, Lecturer (01001340579 ext. +2, y.eldebakey@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of enhanced recovery after pancreatico-dudenectomy (time frame: 1 month after surgery). 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 NCT05192044, which also lists 1 linked publication.
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 Jan 2022.