Pancreas NeoplasmNCT05463328
Open Versus Laparoscopic Assisted Pancreaticoduodenectomy
A study testing laparoscopic assisted pancreaticoduodenectomy and Open pancreaticduodenctomy in people with Pancreas Neoplasm, run by Assiut University.
Trial summary
Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreas Neoplasm
- What is being tested?
- laparoscopic assisted pancreaticoduodenectomy and Open pancreaticduodenctomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age less than 70 years.
- resectable tumour,
- fit for surgery
Who cannot join
- patients with jaundice with serum bilirubin above 200mml/dl.
- patients with bleeding tendency until corrected.
- patients with advanced and metastatic malignancy.
- patients with cardiopulmonary diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Open Versus Laparoscopic Assisted Pancreaticoduodenectomy: Randomized Control Comparative Prospective Study
Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .
Read the detailed description
Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. [1]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers[2,3]. In recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers [4,5]. Laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy[6]. Several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy[7,8]. Limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .Also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.So the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.
- Conditions
- Pancreas Neoplasm
- Being tested
- laparoscopic assisted pancreaticoduodenectomy, Open pancreaticduodenctomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic assisted pancreaticoduodenectomyProcedure or surgery
laparoscopic assisted pancreaticoduodenectomy.
Open pancreaticduodenctomyProcedure or surgery
Open pancreaticduodenctomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic assisted pancreaticoduodenctomy | Experimental | If inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy. Receives: Procedure: laparoscopic assisted pancreaticoduodenectomy |
| Open pancreaticduodenctomy | Active comparator | criteria are met ,these group of patients will undergo open pancreaticoduodenctomy Receives: Procedure: Open pancreaticduodenctomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain.
Compare the post operative pain betweenopen and laparoscopic assisted pancreaticoduodenectomy
Measured: Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation
Blood loss
Compare between the intra operative blood loss in the open and laparoscopic assisted pancreaticoduodenectomy
Measured: Compare the intra operative blood loss between open and laparoscopic assisted pancreaticoduodenectomy during the operation
Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal).
Compare the rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) between the open and laparoscopic assisted pancreaticoduodenctomy
Measured: Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) in the first month after operation
Secondary outcomes (4)
Postoperative haemorrhage
Compare between the postoperative haemorrhage by cc in the open and laparoscopic assisted pancreaticoduodenectomy
Measured: In the first 2 weeks
Postoperative wound infection.
Compare between the postoperative wound infection in the open and laparoscopic assisted pancreaticoduodenectomy
Measured: In the first 2 weeks
Starting oral feeding
Compare between starting oral feeding in the open and laparoscopic assisted pancreaticoduodenectomy
Measured: In the first 3 days after operation
Postoperative 30 days mortality rate.
Compare between the Postoperative 30 days mortality rate in the open and laparoscopic assisted pancreaticoduodenectomy
Measured: In the first 30days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreas NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463328
- Sponsor's protocol ID
- pancreaticoduodenectomy
- Status last verified
- Jul 2022
- First submitted
- 8 Apr 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Newhook TE, LaPar DJ, Lindberg JM, Bauer TW, Adams RB, Zaydfudim VM. Morbidity and mortality of pancreaticoduodenectomy for benign and premalignant pancreatic neoplasms. J Gastrointest Surg. 2015 Jun;19(6):1072-7. doi: 10.1007/s11605-015-2799-y. Epub 2015 Mar 24.
PubMed 25801594Erratum to "Cancer statistics, 2021". CA Cancer J Clin. 2021 Jul;71(4):359. doi: 10.3322/caac.21669. Epub 2021 Apr 19. No abstract available.
PubMed 34232515Correction to Lancet Gastroenterol Hepatol 2019; 4: 934-47. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):e2. doi: 10.1016/S2468-1253(20)30018-2. No abstract available.
PubMed 32061329Bausch D, Keck T. Minimally Invasive Surgery of Pancreatic Cancer: Feasibility and Rationale. Visc Med. 2018 Dec;34(6):440-443. doi: 10.1159/000495324. Epub 2018 Nov 28.
PubMed 30675490
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Laparoscopic Assisted Pancreaticoduodenectomy: Randomized Control Comparative Prospective Study
- ClinicalTrials.gov ID
- NCT05463328
- Acronym / sponsor ID
- pancreaticoduodenectomy
- Conditions
- Pancreas Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 19 Jul 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.
Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .
Detailed description
Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. [1]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers[2,3]. In recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers [4,5]. Laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy[6]. Several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy[7,8]. Limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .Also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.So the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic assisted pancreaticoduodenctomy | Experimental | Procedure: laparoscopic assisted pancreaticoduodenectomyIf inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy. |
| Open pancreaticduodenctomy | Active comparator | Procedure: Open pancreaticduodenctomycriteria are met ,these group of patients will undergo open pancreaticoduodenctomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age less than 70 years.
- resectable tumour,
- fit for surgery
Key exclusion criteria (4 listed)
- patients with jaundice with serum bilirubin above 200mml/dl.
- patients with bleeding tendency until corrected.
- patients with advanced and metastatic malignancy.
- patients with cardiopulmonary diseases.
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 |
|---|---|---|
| laparoscopic assisted pancreaticoduodenectomylaparoscopic assisted pancreaticoduodenectomy. | Procedure or surgery | Laparoscopic assisted pancreaticoduodenctomy |
| Open pancreaticduodenctomyOpen pancreaticduodenctomy | Procedure or surgery | Open pancreaticduodenctomy |
Primary outcome
post operative pain.
Time frame: Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation
Compare the post operative pain betweenopen and laparoscopic assisted pancreaticoduodenectomy
Blood loss
Time frame: Compare the intra operative blood loss between open and laparoscopic assisted pancreaticoduodenectomy during the operation
Compare between the intra operative blood loss in the open and laparoscopic assisted pancreaticoduodenectomy
Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal).
Time frame: Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) in the first month after operation
Compare the rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) between the open and laparoscopic assisted pancreaticoduodenctomy
4 secondary outcomes
Postoperative haemorrhage
Time frame: In the first 2 weeks
Postoperative wound infection.
Time frame: In the first 2 weeks
Starting oral feeding
Time frame: In the first 3 days after operation
Postoperative 30 days mortality rate.
Time frame: In the first 30days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Background: PubMed 25801594Newhook TE, LaPar DJ, Lindberg JM, Bauer TW, Adams RB, Zaydfudim VM. Morbidity and mortality of pancreaticoduodenectomy for benign and premalignant pancreatic neoplasms. J Gastrointest Surg. 2015 Jun;19(6):1072-7. doi: 10.1007/s11605-015-2799-y. Epub 2015 Mar 24.
- Background: PubMed 34232515Erratum to "Cancer statistics, 2021". CA Cancer J Clin. 2021 Jul;71(4):359. doi: 10.3322/caac.21669. Epub 2021 Apr 19. No abstract available.
- Background: PubMed 32061329Correction to Lancet Gastroenterol Hepatol 2019; 4: 934-47. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):e2. doi: 10.1016/S2468-1253(20)30018-2. No abstract available.
- Background: PubMed 30675490Bausch D, Keck T. Minimally Invasive Surgery of Pancreatic Cancer: Feasibility and Rationale. Visc Med. 2018 Dec;34(6):440-443. doi: 10.1159/000495324. Epub 2018 Nov 28.
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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?
A study testing laparoscopic assisted pancreaticoduodenectomy and Open pancreaticduodenctomy in people with Pancreas Neoplasm, 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 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 19 Jul 2022. 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 mohammed aly ahmed, Assist.lecturer (01067575588, mohamed1234ali1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain. (time frame: Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation). The study lists 3 primary outcomes in all. 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 NCT05463328, which also lists 4 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 19 Jul 2022.