PancreaticoduodenectomyNCT06863389
Comparison of Chen's U-suture Technique with Duct-to-Mucosa Anastomosis and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy
An observational study of Pancreaticoduodenectomy, run by Chen Xiaoping.
Trial summary
Data of patients treated with pancreaticoduodenectomy in 21 hospitals from January 2014 to December 2019 were retrospectively collected and classified to Chen's group, duct-to-mucosa group and invagination group according to different pancreaticojejunostomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- Chen's U-suture technique, invagination and Duct-to-Mucosa
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 5,788 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent open pancreaticoduodenectomy during the period from January 1, 2014 to December 31, 2019 at 21 hospitals in China were restrospectively recruited. All patients underwent standard open pancreaticoduodenectomy with Child reconstruction which were performed by senior hepato-pancreato-biliary surgeons who performed over 200 pancreaticoduodenectomy per year. According to different PJ, patients were divided into three groups: Chen's, IG, DTM.
Who may be able to join
- open pancreaticoduodenectomy
- Chen's U-suture technique or invagination or duct-to-mucosa anastomosis
Who cannot join
- missing data
About this study
Data of patients treated with pancreaticoduodenectomy in 21 hospitals from January 2014 to December 2019 were retrospectively collected and classified to Chen's group, duct-to-mucosa group and invagination group according to different pancreaticojejunostomy. Propensity score matching analysis was performed to balance the baseline differences among three groups. The surgical outcomes were compared. Independent risk factors for postoperative pancreatic fistula were confirmed by logistic regression analysis, and subgroup analysis was also conducted.
- Conditions
- Pancreaticoduodenectomy
- Being tested
- Chen's U-suture technique, invagination, Duct-to-Mucosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chen's U-suture techniqueProcedure or surgery
Initially, an approximately 2 cm cut edge of the pancreas remnant was mobilized and a incision of the jejunal loop was conducted slightly shorter than the pancreatic remnant. Using dual-needle 3-0 prolene suture for anastomosis, needle A went through the entire intestinal wall from the posterior wall about 1.5 cm away from the resection margin of the jejunum loop, then went through the superior boarder of the pancreas from posterior to anterior. To suture the anterior wall of the jejunum loop, the stitch next entered from the resection margin of the jejunum loop and kept it within the seromuscular layer from proximal to distal, and got out from about 1.5 cm away from the resection margin. Needle B repeated the aforementioned procedures with a parallel distance about 1.0 cm between needle A. Generally, the whole anastomosis needed two to four identical stitches. The stitches should overlap each other to reduce pancreatic leakage. Once all the stitches were finished and tighte
invaginationProcedure or surgery
Firstly, using 3-0 silk sutures, the pancreatic capsule and the serosa of the jejunal loop were anastomosed interruptedly to constitute the posterior outer layer of the anastomosis. Secondly, a jejunotomy with an appropriate size was performed and the inner layer (including posterior and anterior) of invagination was formed by two 5-0 prolene sutures with a continuous running between the pancreatic parenchyma and the full-thickness jejunum. Thirdly, the anterior outer layer was sutured in line with the first step.
Duct-to-MucosaProcedure or surgery
Briefly, Duct-to-Mucosa should make a opening matched to the pancreatic duct and was also performed by two layers. One was the outer layer in both the anterior and posterior walls of the anastomosis which were formed by interrupted 3-0 silk sutures betweent the pancreatic capsule and the jejunal serosa. The other was the inner layer performed in eight to twelve stitches from pancreatic duct to jejunal mucosa with 5-0 prolene sutures.
| Study group | Role | What they receive |
|---|---|---|
| Chen's group | performing pancreaticojejunostomy by using Chen's U-suture technique Receives: Procedure: Chen's U-suture technique | |
| Invagination group | performing pancreaticojejunostomy by using invagination method Receives: Procedure: invagination | |
| Duct-to-Mucosa group | performing pancreaticojejunostomy by using duct-to-mucosa method Receives: Procedure: Duct-to-Mucosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pancreatic fistula
Postoperative pancreatic fistula was diagnosed and graded in accordance with the 2016 update definition of the International study group (ISGPS)
Measured: postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study startJan 2014
- Primary completionDec 2019
- Study completionJun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,788 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chen Xiaoping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Xiaoping, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863389
- Sponsor's protocol ID
- Chen'sUsuture1
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Chen's U-suture Technique with Duct-to-Mucosa Anastomosis and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT06863389
- Acronym / sponsor ID
- Chen'sUsuture1
- Conditions
- Pancreaticoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,788 participants (actual)
- Lead sponsor
- Chen XiaopingUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jun 2024 (actual)
- First posted
- 7 Mar 2025 (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.
Data of patients treated with pancreaticoduodenectomy in 21 hospitals from January 2014 to December 2019 were retrospectively collected and classified to Chen's group, duct-to-mucosa group and invagination group according to different pancreaticojejunostomy. Propensity score matching analysis was performed to balance the baseline differences among three groups. The surgical outcomes were compared. Independent risk factors for postoperative pancreatic fistula were confirmed by logistic regression analysis, and subgroup analysis was also conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chen's group | – | Procedure: Chen's U-suture techniqueperforming pancreaticojejunostomy by using Chen's U-suture technique |
| Invagination group | – | Procedure: invaginationperforming pancreaticojejunostomy by using invagination method |
| Duct-to-Mucosa group | – | Procedure: Duct-to-Mucosaperforming pancreaticojejunostomy by using duct-to-mucosa method |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent open pancreaticoduodenectomy during the period from January 1, 2014 to December 31, 2019 at 21 hospitals in China were restrospectively recruited. All patients underwent standard open pancreaticoduodenectomy with Child reconstruction which were performed by senior hepato-pancreato-biliary surgeons who performed over 200 pancreaticoduodenectomy per year. According to different PJ, patients were divided into three groups: Chen's, IG, DTM.
Key inclusion criteria (2 listed)
- open pancreaticoduodenectomy
- Chen's U-suture technique or invagination or duct-to-mucosa anastomosis
Key exclusion criteria (1 listed)
- missing data
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 |
|---|---|---|
| Chen's U-suture techniqueInitially, an approximately 2 cm cut edge of the pancreas remnant was mobilized and a incision of the jejunal loop was conducted slightly shorter than the pancreatic remnant. Using dual-needle 3-0 prolene suture for anastomosis, needle A went through the entire intestinal wall from the posterior wall about 1.5 cm away from the resection margin of the jejunum loop, then went through the superior boarder of the pancreas from posterior to anterior. To suture the anterior wall of the jejunum loop, the stitch next entered from the resection margin of the jejunum loop and kept it within the seromuscular layer from proximal to distal, and got out from about 1.5 cm away from the resection margin. Needle B repeated the aforementioned procedures with a parallel distance about 1.0 cm between needle A. Generally, the whole anastomosis needed two to four identical stitches. The stitches should overlap each other to reduce pancreatic leakage. Once all the stitches were finished and tighte | Procedure or surgery | Chen's group |
| invaginationFirstly, using 3-0 silk sutures, the pancreatic capsule and the serosa of the jejunal loop were anastomosed interruptedly to constitute the posterior outer layer of the anastomosis. Secondly, a jejunotomy with an appropriate size was performed and the inner layer (including posterior and anterior) of invagination was formed by two 5-0 prolene sutures with a continuous running between the pancreatic parenchyma and the full-thickness jejunum. Thirdly, the anterior outer layer was sutured in line with the first step. | Procedure or surgery | Invagination group |
| Duct-to-MucosaBriefly, Duct-to-Mucosa should make a opening matched to the pancreatic duct and was also performed by two layers. One was the outer layer in both the anterior and posterior walls of the anastomosis which were formed by interrupted 3-0 silk sutures betweent the pancreatic capsule and the jejunal serosa. The other was the inner layer performed in eight to twelve stitches from pancreatic duct to jejunal mucosa with 5-0 prolene sutures. | Procedure or surgery | Duct-to-Mucosa group |
Primary outcome
postoperative pancreatic fistula
Time frame: postoperative 30 days
Postoperative pancreatic fistula was diagnosed and graded in accordance with the 2016 update definition of the International study group (ISGPS)
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 7 Mar 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreaticoduodenectomy, run by Chen Xiaoping.
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 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: finished, as of the sponsor's last update on 7 Mar 2025. 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?
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?
postoperative pancreatic fistula (time frame: postoperative 30 days). 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 7 Mar 2025.