PancreaticoduodenectomyNCT03767959
Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy
A study testing Chen's U-Suture and Classic pancreatic duct to mucosa in people with Pancreaticoduodenectomy, run by Chen Xiaoping at 1 site in China.
Trial summary
To date, pancreaticoduodenectomy (PD) is the only recognized potentially curative therapy for malignant neoplasms located in the peri-ampullary region, and is increasingly being used for the treatment of cancer through the resection of the premalignant precursors for invasive carcinomas.Postoperative pancreatic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- Chen's U-Suture and Classic pancreatic duct to mucosa
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2019to Jul 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 75 years of age, inclusive.
- Patients have a diagnosis of benign and malignant diseases of the pancreatic head and periampullary region and requiring pancreaticoduodenectomy.
- Patients have not been treated with any anticancer medications and immunotherapy prior to surgery
- Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc., and can generally tolerable for surgery.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Female subjects who are pregnant or breastfeeding.
- Patients scheduled to undergo pancreatogastrostomy.
- Patients whose pancreatic duct cannot be located.
- Patients with history of previous pancreatic surgery, server acute or chronic disease or surgical contraindication.
- Patients with HIV-infectious or other AIDS-related disease.
- Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Xiaoping Chen, chenxp@163.com
About this study
Official title: Evaluation of Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy
To date, pancreaticoduodenectomy (PD) is the only recognized potentially curative therapy for malignant neoplasms located in the peri-ampullary region, and is increasingly being used for the treatment of cancer through the resection of the premalignant precursors for invasive carcinomas.Postoperative pancreatic fistula (POPF) is one of the most common complications associated with substantial clinical implications following PD, which significantly affects mortality rate, length of hospital stay, and overall hospital costs. Therefore, the prevention of POPF has always been a high priority for our group as well as other international surgical groups. In 1995, investigators' group established the Chen's U-stitch approach, which was a new technique of end-to-end invaginated pancreaticojejunostomy with transpancreatic transverse U-sutures after PD, and the preliminary results were quite encouraging at that time. Thus, investigators intend to conduct a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of the new technique.
Read the detailed description
This is a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of Chen's U-Suture technique for pancreaticojejunostomy following pancreaticoduodenectomy. Investigators plan to enroll 960 patients in this study and eligible patients will be randomly divided into two groups. One group will use Chen's U-Suture technique and other group will use classic duct-to-mucosa technique. All patients will be followed up for 3 month after surgery, and primary outcome is POPF, other outcome such as duration of operation, grade of POPF, morbidity, mortality, length of hospital stay, reoperation rate, postoperative pancreatic function and postoperative incidence of chronic pancreatic diseases.
- Conditions
- Pancreaticoduodenectomy
- Being tested
- Chen's U-Suture, Classic pancreatic 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-SutureProcedure or surgery
Chen's U-Suture is a new technique of the invaginated end-to-end pancreaticojejunostomy with transpancreatic transverse U-sutures
Classic pancreatic duct to mucosaProcedure or surgery
A Classical anastomosis technique for Pancreaticojejunostomy
| Study group | Role | What they receive |
|---|---|---|
| Chen's U-Suture | Experimental | Patients in this group will treated by Chen's U-suture technique in pancreaticojejunostomy. Receives: Procedure: Chen's U-Suture |
| Classic pancreatic duct to mucosa | Active comparator | Patients in this group will treated by classic pancreatic duct to mucosa technique in pancreaticojejunostomy. Receives: Procedure: Classic pancreatic duct to mucosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pancreatic Fistula(POPF)
POPF will be strictly classified according to IGSPF criteria
Measured: Within 30 days after surgery
Secondary outcomes (8)
Duration of operation
The time of operation count by minute.
Measured: Intraoperative
Grade of POPF
The grade of POPF will be strictly classified according to IGSPF criteria
Measured: Within 30 days after surgery
Morbidity
The incidence of operative complications within 90 days after surgery.
Measured: Within 90 days after surgery
Mortality
The death occurred within 30 days after surgery
Measured: Within 30 days after surgery
Length of hospital stay after surgery
Days between surgery and hospital discharge
Measured: From first day after surgery to release from hospital (anticipate 5 days minimally)
Reoperation rate
The incidence of reoperation within 1 year after surgery.
Measured: Within one year after surgery
Postoperative pancreatic function
Postoperative pancreatic function such as blood glucose, blood diastasum diastace, urine amylase, etc.
Measured: Within one year after surgery
Postoperative incidence of chronic pancreatic diseases
The incidence of chronic pancreatic diseases, the chronic pancreatic diseases include chronic pancreatitis.
Measured: Within one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start24 Jun 2019
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Xiaoping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Xiaoping, Tongji Hospital
- Investigators
- Xiaoping Chen, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767959
- Sponsor's protocol ID
- C201811
- Status last verified
- Mar 2020
- First submitted
- 15 Nov 2018
- Last updated
- 4 Mar 2020
- 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 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT03767959
- Acronym / sponsor ID
- C201811
- Conditions
- Pancreaticoduodenectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Chen XiaopingUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 7 Dec 2018 (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.
To date, pancreaticoduodenectomy (PD) is the only recognized potentially curative therapy for malignant neoplasms located in the peri-ampullary region, and is increasingly being used for the treatment of cancer through the resection of the premalignant precursors for invasive carcinomas.Postoperative pancreatic fistula (POPF) is one of the most common complications associated with substantial clinical implications following PD, which significantly affects mortality rate, length of hospital stay, and overall hospital costs. Therefore, the prevention of POPF has always been a high priority for our group as well as other international surgical groups. In 1995, investigators' group established the Chen's U-stitch approach, which was a new technique of end-to-end invaginated pancreaticojejunostomy with transpancreatic transverse U-sutures after PD, and the preliminary results were quite encouraging at that time. Thus, investigators intend to conduct a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of the new technique.
Detailed description
This is a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of Chen's U-Suture technique for pancreaticojejunostomy following pancreaticoduodenectomy. Investigators plan to enroll 960 patients in this study and eligible patients will be randomly divided into two groups. One group will use Chen's U-Suture technique and other group will use classic duct-to-mucosa technique. All patients will be followed up for 3 month after surgery, and primary outcome is POPF, other outcome such as duration of operation, grade of POPF, morbidity, mortality, length of hospital stay, reoperation rate, postoperative pancreatic function and postoperative incidence of chronic pancreatic diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chen's U-Suture | Experimental | Procedure: Chen's U-SuturePatients in this group will treated by Chen's U-suture technique in pancreaticojejunostomy. |
| Classic pancreatic duct to mucosa | Active comparator | Procedure: Classic pancreatic duct to mucosaPatients in this group will treated by classic pancreatic duct to mucosa technique in pancreaticojejunostomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18 to 75 years of age, inclusive.
- Patients have a diagnosis of benign and malignant diseases of the pancreatic head and periampullary region and requiring pancreaticoduodenectomy.
- Patients have not been treated with any anticancer medications and immunotherapy prior to surgery
- Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc., and can generally tolerable for surgery.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (6 listed)
- Female subjects who are pregnant or breastfeeding.
- Patients scheduled to undergo pancreatogastrostomy.
- Patients whose pancreatic duct cannot be located.
- Patients with history of previous pancreatic surgery, server acute or chronic disease or surgical contraindication.
- Patients with HIV-infectious or other AIDS-related disease.
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-SutureChen's U-Suture is a new technique of the invaginated end-to-end pancreaticojejunostomy with transpancreatic transverse U-sutures | Procedure or surgery | Chen's U-Suture |
| Classic pancreatic duct to mucosaA Classical anastomosis technique for Pancreaticojejunostomy | Procedure or surgery | Classic pancreatic duct to mucosa |
Primary outcome
Postoperative Pancreatic Fistula(POPF)
Time frame: Within 30 days after surgery
POPF will be strictly classified according to IGSPF criteria
8 secondary outcomes
Duration of operation
Time frame: Intraoperative
Grade of POPF
Time frame: Within 30 days after surgery
Morbidity
Time frame: Within 90 days after surgery
Mortality
Time frame: Within 30 days after surgery
Length of hospital stay after surgery
Time frame: From first day after surgery to release from hospital (anticipate 5 days minimally)
Reoperation rate
Time frame: Within one year after surgery
Postoperative pancreatic function
Time frame: Within one year after surgery
Postoperative incidence of chronic pancreatic diseases
Time frame: Within one year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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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.
Xiaoping Chen principal investigator
Tongji 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 Chen's U-Suture and Classic pancreatic duct to mucosa in people with Pancreaticoduodenectomy, run by Chen Xiaoping 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 5 inclusion and 6 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 4 Mar 2020. 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 Xiaoping Chen (86-027-83663400, chenxp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pancreatic Fistula(POPF) (time frame: Within 30 days after surgery). 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 4 Mar 2020.