Laparoscopic PancreaticoduodenectomyLPDEXCEPTNCT05808894
Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT)
A study testing extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy in people with Laparoscopic Pancreaticoduodenectomy, run by Xinrui Zhu，MD at 1 site in China.
Trial summary
The investigators conduct the clinical randomized controlled trial to evaluate the superiority of extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Pancreaticoduodenectomy
- What is being tested?
- extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Jun 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with benign or resectable malignant tumors of the lower common bile duct, Vater ampulla, head or uncinate process of the pancreas.
- 18 years old < age < 80 years old, no gender limit.
- Patient is expected survival beyond 3 months.
- No pregnancy or pregnancy plan within 3 months after surgery.
- Nutrition risk score <3 according to the Nutritional Risk Screening for Inpatients 2002 (NRS2002) standard score.
- No contraindication to surgery for anesthetic evaluation.
- The subjects voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up.
Who cannot join
- Patients with borderline resectable and unresectable malignancies.
- Patients undergoing neoadjuvant chemotherapy or radiotherapy.
- Patients with tumors exceeding the level of the gastroduodenal artery as measured by preoperative radiography.
- Intraoperative exploration reveals tumor adhesions with portal vein-superior mesenteric vein, requiring revascularization and reconstruction.
- Operation transfers to open.
- Operation transfers to other procedure.
- The main pancreatic duct can not be found intraoperatively, the duct-to-mucosa pancreaticojejunostomy can not be operated.
Trial locations and contacts
1 site in 1 country.
Yunqiang Cai contact
About this study
Official title: Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT): a Multicenter Randomized Controlled Trial
The investigators conduct the clinical randomized controlled trial to evaluate the superiority of extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD). The participants in the study group obtain extended pancreatic neck transection during LPD, while participants in the control group conventional pancreatic neck transection. The purposes of this study include: 1.Primary objective: To compare the incidence of clinically relevant pancreatic fistula (grades B-C according International Study Group on Pancreatic Surgery) between the study group and the control group. 2.Secondary objective: To compare the incidence of postoperative morbidity (Clavien-Dindo score ≥3）between the two groups. To compare the location of pancreatic duct and the surgical performance of pancreaticojejunostomy between the two groups.
- Conditions
- Laparoscopic Pancreaticoduodenectomy
- Being tested
- extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy
- Keywords
- laparoscopic pancreaticoduodenectomy, pancreatic neck transection level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended pancreatic neck transection during laparoscopic pancreaticoduodenectomyProcedure or surgery
Transect the pancreatic neck at ≥5mm and ≤10mm beyond the left side of the portal vein.
| Study group | Role | What they receive |
|---|---|---|
| extended transection group | Experimental | the patients in extended transection group obtain extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy. Receives: Procedure: extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy |
| conventional transection group | No intervention | the patients in conventional transection group obtain conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of clinically relevant pancreatic fistula
the incidence of the clinically relevant pancreatic fistula according the International Study Group of Pancreatic Surgery's definition and grading
Measured: 3 months postoperatively
Secondary outcomes (4)
location of the pancreatic duct in the pancreatic transverse section
Before performing the pancreaticojejunostomy, place the pancreatic transverse section in the central position of the lens. Measure the anterior-posterior diameter of the pancreas and the distance of the pancreatic duct from the back of the pancreas. The location of the pancreatic duct in the pancreatic transverse section is equal to the ratio of the distance of the pancreatic duct from the back of the pancreas to the anterior-posterior diameter of the pancreas.
Measured: intraoperatively
surgical performance of pancreaticojejunostomy
the duration of pancreaticojejunostomy
Measured: intraoperatively
postoperative morbidity
postoperative morbidity (Clavien-Dindo score ≥3）within 3 months postoperatively
Measured: 3 months postoperatively
postoperative mortality
mortality within 3 months postoperatively
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study startAug 2023 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic PancreaticoduodenectomyStudies 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
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinrui Zhu，MD
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University, Shandong Provincial Hospital, Qilu Hospital of Shandong University
- Responsible party
- Sponsor-investigator, Xinrui Zhu，MD, West China Hospital
- Investigators
- Bing Peng, Professor, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808894
- Sponsor's protocol ID
- 2023-167-1
- Acronym
- LPDEXCEPT
- Status last verified
- Jul 2023
- First submitted
- 14 Mar 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bardol T, Delicque J, Hermida M, Herrero A, Guiu B, Fabre JM, Souche R. Neck transection level and postoperative pancreatic fistula after pancreaticoduodenectomy: A retrospective cohort study of 195 patients. Int J Surg. 2020 Oct;82:43-50. doi: 10.1016/j.ijsu.2020.08.001. Epub 2020 Aug 22.
PubMed 32841726Jwa EK, Hwang S. Extended pancreatic transection for secure pancreatic reconstruction during pancreaticoduodenectomy. Ann Hepatobiliary Pancreat Surg. 2017 Aug;21(3):138-145. doi: 10.14701/ahbps.2017.21.3.138. Epub 2017 Aug 31.
PubMed 28990000Strasberg SM, Drebin JA, Mokadam NA, Green DW, Jones KL, Ehlers JP, Linehan D. Prospective trial of a blood supply-based technique of pancreaticojejunostomy: effect on anastomotic failure in the Whipple procedure. J Am Coll Surg. 2002 Jun;194(6):746-58; discussion 759-60. doi: 10.1016/s1072-7515(02)01202-4.
PubMed 12081065Subar D, Pietrasz D, Fuks D, Gayet B. A novel technique for reducing pancreatic fistulas after pancreaticojejunostomy. J Surg Case Rep. 2015 Jul 9;2015(7):rjv074. doi: 10.1093/jscr/rjv074.
PubMed 26160766You J, Zhang J, Cai H, Wang X, Wang H, Li Y, Yu C, Wang L, Zhou X, Peng B, Cai Y. Extended pancreatic neck transection versus conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPDEXCEPT): protocol for a multicentre superiority randomised controlled trial. BMJ Open. 2024 Jan 10;14(1):e078092. doi: 10.1136/bmjopen-2023-078092.
PubMed 38199635
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT): a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05808894
- Acronym / sponsor ID
- LPDEXCEPT / 2023-167-1
- Conditions
- Laparoscopic Pancreaticoduodenectomy
- Keywords
- laparoscopic pancreaticoduodenectomy, pancreatic neck transection level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Xinrui Zhu，MDUniversity, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University, Shandong Provincial Hospital, Qilu Hospital of Shandong University
- Study start
- Aug 2023 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Apr 2023 (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 investigators conduct the clinical randomized controlled trial to evaluate the superiority of extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD). The participants in the study group obtain extended pancreatic neck transection during LPD, while participants in the control group conventional pancreatic neck transection. The purposes of this study include: 1.Primary objective: To compare the incidence of clinically relevant pancreatic fistula (grades B-C according International Study Group on Pancreatic Surgery) between the study group and the control group. 2.Secondary objective: To compare the incidence of postoperative morbidity (Clavien-Dindo score ≥3）between the two groups. To compare the location of pancreatic duct and the surgical performance of pancreaticojejunostomy between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extended transection group | Experimental | Procedure: extended pancreatic neck transection during laparoscopic pancreaticoduodenectomythe patients in extended transection group obtain extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy. |
| conventional transection group | No intervention | –the patients in conventional transection group obtain conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with benign or resectable malignant tumors of the lower common bile duct, Vater ampulla, head or uncinate process of the pancreas.
- 18 years old < age < 80 years old, no gender limit.
- Patient is expected survival beyond 3 months.
- No pregnancy or pregnancy plan within 3 months after surgery.
- Nutrition risk score <3 according to the Nutritional Risk Screening for Inpatients 2002 (NRS2002) standard score.
Key exclusion criteria (7 listed)
- Patients with borderline resectable and unresectable malignancies.
- Patients undergoing neoadjuvant chemotherapy or radiotherapy.
- Patients with tumors exceeding the level of the gastroduodenal artery as measured by preoperative radiography.
- Intraoperative exploration reveals tumor adhesions with portal vein-superior mesenteric vein, requiring revascularization and reconstruction.
- Operation transfers to open.
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 |
|---|---|---|
| extended pancreatic neck transection during laparoscopic pancreaticoduodenectomyTransect the pancreatic neck at ≥5mm and ≤10mm beyond the left side of the portal vein. | Procedure or surgery | extended transection group |
Primary outcome
the incidence of clinically relevant pancreatic fistula
Time frame: 3 months postoperatively
the incidence of the clinically relevant pancreatic fistula according the International Study Group of Pancreatic Surgery's definition and grading
4 secondary outcomes
location of the pancreatic duct in the pancreatic transverse section
Time frame: intraoperatively
surgical performance of pancreaticojejunostomy
Time frame: intraoperatively
postoperative morbidity
Time frame: 3 months postoperatively
postoperative mortality
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 32841726Bardol T, Delicque J, Hermida M, Herrero A, Guiu B, Fabre JM, Souche R. Neck transection level and postoperative pancreatic fistula after pancreaticoduodenectomy: A retrospective cohort study of 195 patients. Int J Surg. 2020 Oct;82:43-50. doi: 10.1016/j.ijsu.2020.08.001. Epub 2020 Aug 22.
- Background: PubMed 28990000Jwa EK, Hwang S. Extended pancreatic transection for secure pancreatic reconstruction during pancreaticoduodenectomy. Ann Hepatobiliary Pancreat Surg. 2017 Aug;21(3):138-145. doi: 10.14701/ahbps.2017.21.3.138. Epub 2017 Aug 31.
- Background: PubMed 12081065Strasberg SM, Drebin JA, Mokadam NA, Green DW, Jones KL, Ehlers JP, Linehan D. Prospective trial of a blood supply-based technique of pancreaticojejunostomy: effect on anastomotic failure in the Whipple procedure. J Am Coll Surg. 2002 Jun;194(6):746-58; discussion 759-60. doi: 10.1016/s1072-7515(02)01202-4.
- Background: PubMed 26160766Subar D, Pietrasz D, Fuks D, Gayet B. A novel technique for reducing pancreatic fistulas after pancreaticojejunostomy. J Surg Case Rep. 2015 Jul 9;2015(7):rjv074. doi: 10.1093/jscr/rjv074.
- Derived from this study: PubMed 38199635You J, Zhang J, Cai H, Wang X, Wang H, Li Y, Yu C, Wang L, Zhou X, Peng B, Cai Y. Extended pancreatic neck transection versus conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPDEXCEPT): protocol for a multicentre superiority randomised controlled trial. BMJ Open. 2024 Jan 10;14(1):e078092. doi: 10.1136/bmjopen-2023-078092.
- 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.
Yunqiang Cai contact
Bing Peng, Professor study chair
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy in people with Laparoscopic Pancreaticoduodenectomy, run by Xinrui Zhu，MD at 1 site in China.
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 7 inclusion and 7 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 Jul 2023. 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 China. 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 Bing Peng (+862862539242, pengbing84@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of clinically relevant pancreatic fistula (time frame: 3 months postoperatively). 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 NCT05808894, which also lists 5 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 20 Jul 2023.