Pancreatic NeoplasmsNCT06661135
Open Versus Total Laparoscopic Pancreaticoduodenectomy
A study testing TLPD total laparoscopic pancreaticoduodenectomy and OPD open pancreaticoduodenectomy in people with Pancreatic Neoplasms and Laparoscopic Pancreaticoduodenectomy, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn more about Total Laparoscopic pancreaticoduodenectomy ( TLPD ) which is performed for participants with pancreatic tumors using the laparoscope. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Laparoscopic Pancreaticoduodenectomy, Whipple Operation
- What is being tested?
- TLPD total laparoscopic pancreaticoduodenectomy and OPD open pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting to the outpatient clinic of Kasr Alainy Hospitals with pancreatic head tumors, duodenal tumors, ampullary, or periampullary tumors who were candidates for either open or laparoscopic pancreaticoduodenectomy
- Patients who accepted to participate in the study.
Who cannot join
- Patients who were deemed inoperable or irresectable tumors by preoperative investigations.
- Patients with history of previous laparotomies.
- Patients with complex ventral hernias.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Laparoscopic Versus Open Pancreaticoduodenectomy: a Prospective Comparative Clinical Study
The goal of this clinical trial is to learn more about Total Laparoscopic pancreaticoduodenectomy ( TLPD ) which is performed for participants with pancreatic tumors using the laparoscope.
TLPD is an operation that includes excision of the tumor with adjacent parts of the head of the pancreas, the duodenum and the part of the external biliary system . In the final step during surgery, and to reconnect the bowel after excision of the tumor, multiple anastomoses or connections will be made by the surgeon.
Read more
To get valid results , the investigators performed this randomized controlled trial that compare TLPD with the traditional technique used to remove these tumors through open pancreaticoduodenectomy ( OPD ).
The main questions this study aims to answer are:
Is TLPD superior to open pancraticoduodenectomy ( OPD ) regarding the adequacy of surgical tumor excision ?
Is TLPD lower than OPD regarding the early complications after surgery ?
Researchers will compare participants receiving TLPD with participants receiving OPD regarding :
The time of the operation. The amount of blood lost during surgery. Complications that may happen during or after surgery. Time of recovery after surgery. Duration to amputation. Duration of hospital stay. The adequacy of resection .
Read the detailed description
Pancreaticoduodenectomy (PD) is a major, complex abdominal surgery that involves removing the pancreatic head together with the common bile duct (CBD) and duodenum. It is usually associated with complications that can severely affect patients' health and lead to mortality.
Pancreaticoduodenectomy is mainly indicated for patients with malignant masses in the head of pancreas and the periampullary region and can be the treatment solution for these patients, providing them with a cure or prolonging their survival. Pancreaticoduodenectomy can also be indicated for some pancreatic cystic neoplasms, particularly intraductal papillary mucinous neoplasms (IPMNs) that can turn malignant, neuroendocrine tumors, metastatic lesions to the pancreas, gastrointestinal stromal tumors, pancreatitis, and major pancreatic injury.
Pancreaticoduodenectomy was not generally accepted until the report introduced by Whipple in 1935 about his successful two-stage PD.. After about five years, Whipple conducted the first anatomic one-stage PD, including an antrectomy and a complete duodenectomy for a pancreatic head tumor.
Pancreaticoduodenectomy has been traditionally performed with an open approach. In 1994, Gagner and Pomp described laparoscopic PD (LPD). In their follow-up study, laparoscopic PD was concluded to have a high conversion rate with no advantages over open PD (OPD). Since then, laparoscopic approaches have been growingly reported, with ongoing research aiming to assess if LPD, being a minimally invasive approach, can improve postoperative morbidity. Nevertheless, LPD is still not broadly accepted. This study aimed to determine the advantages and disadvantages of performing total laparoscopic pancreaticoduodenectomy compared to the open approach.
- Being tested
- TLPD total laparoscopic pancreaticoduodenectomy, OPD open pancreaticoduodenectomy
- Keywords
- Total laparoscopic pancreaticoduodenectomy, Open vs laparoscopic pancreaticoduodenectomy, Pancreatic neoplasm surgery in developing countries
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLPD total laparoscopic pancreaticoduodenectomyProcedure or surgery
It includes removal of the pancreatic or duodenal tumors using the laparoscopy
OPD open pancreaticoduodenectomyProcedure or surgery
It includes removal of the pancreatic or duodenal tumors using the open technique
| Study group | Role | What they receive |
|---|---|---|
| TLPD | Experimental | This is the group that will receive laparoscopic pancreaicoduodenectomy trocars were inserted (between 5 and 6 trocars were required) and pneumoperitoneum induction was done. The surgeries were performed as previously described . Single loop reconstruction was adopted which involved the formation of all three anastomoses (pancreatico-jejeunostomy, hepatico-jejeunostomy, and gastro-jejeunostomy) on a single jejunal loop. The distance between the hepatico-jejeunostomy, and gastro-jejeunostomy was adjusted at 60 cm for all patients. Receives: Procedure: TLPD total laparoscopic pancreaticoduodenectomy |
| OPD | Active comparator | this group will receive open PD In the OPD group, a bilateral abdominal subcost incision was performed for open surgery Receives: Procedure: OPD open pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Time spent in hospital in days after surgery
Measured: From the date of surgery of every participant to the date of its discharge from hospital or death whichever comes first, assessed up to 3 months .
Length of postoperative surgical ICU stay
Length of postoperative surgical ICU stay In days
Measured: From the date of admission to SICU ( surgical intensive care unit ) after surgery to the date of discharge to ward or death whichever comes first, assessed up to 3 months .
Amount of blood loss
Amount of blood lost intraoperative assessed in milliliters
Measured: From start of surgery till skin closure
Amount of intraoperative blood transfusion
Amount of intraoperative PRBC units transfused intraoperative
Measured: From start of surgery of every participant till skin closure
30-day mortality
Reporting Death if happens in the first month postoperatively
Measured: From the date of surgery till one month after
Operative time in minutes
Time spent in surgery
Measured: From time of skin incision till time of skin closure
Secondary outcomes (5)
Severity of Postoperative pain
Assessing postoperative pain daily postoperative using visual analogue score that is a scale of grades from 0 to 10 , with 0 means no pain perceived and 10 indicates the worst pain possible perceived
Measured: From awakening after surgery ( day 0 ) till ( day 7 ) afterwards
Gastrointestinal recovery ( time to tolerate oral intake)
Time to tolerate oral fluid intake without vomiting . Usually the participants were instructed to take fluids on day 2 after surgery and continue if tolerating and no vomiting occurred for one complete day
Measured: From Day two ( D2 ) after surgery for every participant till the date of tolerating oral fluids without vomiting for one complete day , up to two Weeks after surgery
Lymph node yield after surgery
Number of lymph nodes harvested
Measured: It takes 5 days after surgery for the pathological assessment to be completed
Ratio of positive lymph nodes to total number of lymph nodes harvested
Ratio of positive lymph nodes to total number of lymph nodes harvested
Measured: It takes 5 days after surgery for the pathological assessment to be completed
State of resection margins after pathological assessment
State of specimen margins ( free or infiltrated by Tumor )
Measured: It takes 5 days after surgery for the pathological assessment to be completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Sep 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
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 Pancreatic NeoplasmsStudies 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
- Model description
- The included patients were equally randomized into two groups: the OPD group, which included patients that would undergo the traditional open procedure, and the LPD group, which included patients that would be subjected to the laparoscopic approach.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of general surgery Cairo University
- Responsible party
- Principal investigator, Abdelkarem Ahmed Abdelkarem Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661135
- Sponsor's protocol ID
- Pancreaticoduodenectomy
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All scientific individual participant data will be ready for sharing including ( age, sex, associated commorbidies, size of the tumor , time of surgery, type of surgery, hospital stay , SICU stay , resection margin results , units of blood transfusion ,….) abiding in the same time to our local research ethical committee rules
Publications
Mostafa MS, Hamour D, Aiad GAN, Balamoun HA, Khattab MH, Shazly MN, Nageeb ME, Mohamed AAA. Laparoscopic versus open pancreatoduodenectomy: a pilot randomized trial in a developing African country. Surg Endosc. 2026 Feb;40(2):1641-1650. doi: 10.1007/s00464-025-12377-x. Epub 2025 Dec 4.
PubMed 41345531
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Laparoscopic Versus Open Pancreaticoduodenectomy: a Prospective Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT06661135
- Acronym / sponsor ID
- Pancreaticoduodenectomy
- Keywords
- Total laparoscopic pancreaticoduodenectomy, Open vs laparoscopic pancreaticoduodenectomy, Pancreatic neoplasm surgery in developing countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Department of general surgery Cairo University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 28 Oct 2024 (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 goal of this clinical trial is to learn more about Total Laparoscopic pancreaticoduodenectomy ( TLPD ) which is performed for participants with pancreatic tumors using the laparoscope.
TLPD is an operation that includes excision of the tumor with adjacent parts of the head of the pancreas, the duodenum and the part of the external biliary system . In the final step during surgery, and to reconnect the bowel after excision of the tumor, multiple anastomoses or connections will be made by the surgeon.
To get valid results , the investigators performed this randomized controlled trial that compare TLPD with the traditional technique used to remove these tumors through open pancreaticoduodenectomy ( OPD ).
The main questions this study aims to answer are:
Is TLPD superior to open pancraticoduodenectomy ( OPD ) regarding the adequacy of surgical tumor excision ?
Is TLPD lower than OPD regarding the early complications after surgery ?
Researchers will compare participants receiving TLPD with participants receiving OPD regarding :
The time of the operation. The amount of blood lost during surgery. Complications that may happen during or after surgery. Time of recovery after surgery. Duration to amputation. Duration of hospital stay. The adequacy of resection .
Detailed description
Pancreaticoduodenectomy (PD) is a major, complex abdominal surgery that involves removing the pancreatic head together with the common bile duct (CBD) and duodenum. It is usually associated with complications that can severely affect patients' health and lead to mortality.
Pancreaticoduodenectomy is mainly indicated for patients with malignant masses in the head of pancreas and the periampullary region and can be the treatment solution for these patients, providing them with a cure or prolonging their survival. Pancreaticoduodenectomy can also be indicated for some pancreatic cystic neoplasms, particularly intraductal papillary mucinous neoplasms (IPMNs) that can turn malignant, neuroendocrine tumors, metastatic lesions to the pancreas, gastrointestinal stromal tumors, pancreatitis, and major pancreatic injury.
Pancreaticoduodenectomy was not generally accepted until the report introduced by Whipple in 1935 about his successful two-stage PD.. After about five years, Whipple conducted the first anatomic one-stage PD, including an antrectomy and a complete duodenectomy for a pancreatic head tumor.
Pancreaticoduodenectomy has been traditionally performed with an open approach. In 1994, Gagner and Pomp described laparoscopic PD (LPD). In their follow-up study, laparoscopic PD was concluded to have a high conversion rate with no advantages over open PD (OPD). Since then, laparoscopic approaches have been growingly reported, with ongoing research aiming to assess if LPD, being a minimally invasive approach, can improve postoperative morbidity. Nevertheless, LPD is still not broadly accepted. This study aimed to determine the advantages and disadvantages of performing total laparoscopic pancreaticoduodenectomy compared to the open approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The included patients were equally randomized into two groups: the OPD group, which included patients that would undergo the traditional open procedure, and the LPD group, which included patients that would be subjected to the laparoscopic approach.
| Arm | Type | Receives |
|---|---|---|
| TLPD | Experimental | Procedure: TLPD total laparoscopic pancreaticoduodenectomyThis is the group that will receive laparoscopic pancreaicoduodenectomy trocars were inserted (between 5 and 6 trocars were required) and pneumoperitoneum induction was done. The surgeries were performed as previously described . Single loop reconstruction was adopted which involved the formation of all three anastomoses (pancreatico-jejeunostomy, hepatico-jejeunostomy, and gastro-jejeunostomy) on a single jejunal loop. The distance between the hepatico-jejeunostomy, and gastro-jejeunostomy was adjusted at 60 cm for all patients. |
| OPD | Active comparator | Procedure: OPD open pancreaticoduodenectomythis group will receive open PD In the OPD group, a bilateral abdominal subcost incision was performed for open surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting to the outpatient clinic of Kasr Alainy Hospitals with pancreatic head tumors, duodenal tumors, ampullary, or periampullary tumors who were candidates for either open or laparoscopic pancreaticoduodenectomy
- Patients who accepted to participate in the study.
Key exclusion criteria (3 listed)
- Patients who were deemed inoperable or irresectable tumors by preoperative investigations.
- Patients with history of previous laparotomies.
- Patients with complex ventral hernias.
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 |
|---|---|---|
| TLPD total laparoscopic pancreaticoduodenectomyIt includes removal of the pancreatic or duodenal tumors using the laparoscopy | Procedure or surgery | TLPD |
| OPD open pancreaticoduodenectomyIt includes removal of the pancreatic or duodenal tumors using the open technique | Procedure or surgery | OPD |
Primary outcome
Length of hospital stay
Time frame: From the date of surgery of every participant to the date of its discharge from hospital or death whichever comes first, assessed up to 3 months .
Time spent in hospital in days after surgery
Length of postoperative surgical ICU stay
Time frame: From the date of admission to SICU ( surgical intensive care unit ) after surgery to the date of discharge to ward or death whichever comes first, assessed up to 3 months .
Length of postoperative surgical ICU stay In days
Amount of blood loss
Time frame: From start of surgery till skin closure
Amount of blood lost intraoperative assessed in milliliters
Amount of intraoperative blood transfusion
Time frame: From start of surgery of every participant till skin closure
Amount of intraoperative PRBC units transfused intraoperative
30-day mortality
Time frame: From the date of surgery till one month after
Reporting Death if happens in the first month postoperatively
Operative time in minutes
Time frame: From time of skin incision till time of skin closure
Time spent in surgery
5 secondary outcomes
Severity of Postoperative pain
Time frame: From awakening after surgery ( day 0 ) till ( day 7 ) afterwards
Gastrointestinal recovery ( time to tolerate oral intake)
Time frame: From Day two ( D2 ) after surgery for every participant till the date of tolerating oral fluids without vomiting for one complete day , up to two Weeks after surgery
Lymph node yield after surgery
Time frame: It takes 5 days after surgery for the pathological assessment to be completed
Ratio of positive lymph nodes to total number of lymph nodes harvested
Time frame: It takes 5 days after surgery for the pathological assessment to be completed
State of resection margins after pathological assessment
Time frame: It takes 5 days after surgery for the pathological assessment to be completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Derived from this study: PubMed 41345531Mostafa MS, Hamour D, Aiad GAN, Balamoun HA, Khattab MH, Shazly MN, Nageeb ME, Mohamed AAA. Laparoscopic versus open pancreatoduodenectomy: a pilot randomized trial in a developing African country. Surg Endosc. 2026 Feb;40(2):1641-1650. doi: 10.1007/s00464-025-12377-x. Epub 2025 Dec 4.
- Individual participant dataSharing planned: Yes. All scientific individual participant data will be ready for sharing including ( age, sex, associated commorbidies, size of the tumor , time of surgery, type of surgery, hospital stay , SICU stay , resection margin results , units of blood transfusion ,….) abiding in the same time to our local research ethical committee rules
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLPD total laparoscopic pancreaticoduodenectomy and OPD open pancreaticoduodenectomy in people with Pancreatic Neoplasms and Laparoscopic Pancreaticoduodenectomy, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 28 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of hospital stay (time frame: From the date of surgery of every participant to the date of its discharge from hospital or death whichever comes first, assessed up to 3 months .). The study lists 6 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 NCT06661135, 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 28 Oct 2024.