Periampullary Carcinoma ResectableNCT07681128
The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy
A study testing Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy and Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy. in people with Periampullary Carcinoma Resectable, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Pancreaticoduodenectomy (PD) is the only curative procedure for periampullary malignant tumors. Although modern perioperative management has greatly reduced postoperative mortality, delayed gastric emptying (DGE) remains one of the most common and troublesome complications after PD, with an incidence up to 30%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periampullary Carcinoma Resectable
- What is being tested?
- Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy and Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, male or female;
- Scheduled to undergo curative pancreaticoduodenectomy (PD);
- Undergoing PD for malignant or borderline tumors, with planned antecolic Billroth II reconstruction;
- Mentally competent and able to provide written informed consent.
Who cannot join
- Age < 18 years;
- Prior diagnosis of gastroparesis;
- Benign disease as the indication for PD;
- Previous history of upper gastrointestinal surgery;
- Preoperative pyloric obstruction;
- Planned pylorus-preserving pancreaticoduodenectomy (PPPD);
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- Patients who have received neoadjuvant or conversion therapy;
- Preoperative glycated hemoglobin (HbA1c) > 7.5%;
- Preoperative total bilirubin level > 200 μmol/L;
- Unable or unwilling to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Yunlong Cui, +86 18622228633, ningyunlong@163.com
About this study
Official title: The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy: A Prospective Single-center Randomized Controlled Trial
Pancreaticoduodenectomy (PD) is the only curative procedure for periampullary malignant tumors. Although modern perioperative management has greatly reduced postoperative mortality, delayed gastric emptying (DGE) remains one of the most common and troublesome complications after PD, with an incidence up to 30%. DGE leads to abdominal distension, nausea, vomiting, intolerance of oral diet, prolonged hospital stay, increased medical costs, delayed adjuvant therapy initiation, and impaired long-term nutritional recovery and quality of life.
Braun anastomosis (BE) can reconstruct the gastrointestinal tract by side-to-side jejunojejunostomy between the afferent and efferent limbs, which may reduce intestinal stasis, bile reflux and afferent limb obstruction, and theoretically lower the risk of postoperative DGE. However, current clinical studies and meta-analyses remain controversial regarding the actual efficacy of BE in preventing DGE after PD. Some studies support that BE can reduce DGE incidence, shorten hospitalization and improve postoperative recovery, while others demonstrate no statistically significant benefit, or even concern about prolonged operative time and technical difficulty. Existing evidence is limited by small sample size, retrospective design and potential selection bias, and high-quality prospective randomized controlled trials are still lacking to confirm the clinical value of BE.
This study is designed as a prospective, single-center, randomized controlled trial, aiming to evaluate the impact of routine Braun anastomosis during digestive tract reconstruction on the incidence and severity of postoperative DGE in patients undergoing pancreaticoduodenectomy for malignant tumors. The results will provide high-level clinical evidence for the rational application of Braun anastomosis in PD reconstruction and guide standardized clinical practice.
- Conditions
- Periampullary Carcinoma Resectable
- Being tested
- Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy, Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.
- Keywords
- Pancreaticoduodenectomy, Braun Anastomosis, Delayed Gastric Emptying
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomyProcedure or surgery
Intervention Group: Patients undergo PD with antecolic Billroth II reconstruction plus Braun enteroenterostomy (BE).
Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.Procedure or surgery
Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.
| Study group | Role | What they receive |
|---|---|---|
| Braun arm | Experimental | PD with Billroth II reconstruction plus Braun anastomosis Receives: Procedure: Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy |
| Non Braun Arm | Other | PD with Billroth II reconstruction alone (without Braun anastomosis) Receives: Procedure: Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed gastric emptying (DGE)
Incidence of delayed gastric emptying (DGE), defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria
Measured: Postoperative days 1, 8, 15, and 22
Secondary outcomes (6)
Length of hospital stay (days)
Comparison of hospital stay duration between the intervention group and the control group.
Measured: From first postoperative day to hospital discharge up to 15 weeks
Treatment cost
Evaluation of the difference in medical expenditure between the intervention group and the control group.
Measured: From the first postoperative day to one year follow-up
Postoperative recovery
Including time to first flatus, time to oral intake, and other related indicators.
Measured: From the first postoperative day to one year follow-up
Bile reflux
Measured: Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.
Proportion of severe complications as defined by the Clavien-Dindo classification
Measured: From the first postoperative day to one year follow-up
Quality of life scores assessed using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire at 30 days postoperatively
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start30 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periampullary Carcinoma ResectableStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681128
- Sponsor's protocol ID
- Braun-HCC
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy: A Prospective Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07681128
- Acronym / sponsor ID
- Braun-HCC
- Conditions
- Periampullary Carcinoma Resectable
- Keywords
- Pancreaticoduodenectomy, Braun Anastomosis, Delayed Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 2 Jul 2026 (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.
Pancreaticoduodenectomy (PD) is the only curative procedure for periampullary malignant tumors. Although modern perioperative management has greatly reduced postoperative mortality, delayed gastric emptying (DGE) remains one of the most common and troublesome complications after PD, with an incidence up to 30%. DGE leads to abdominal distension, nausea, vomiting, intolerance of oral diet, prolonged hospital stay, increased medical costs, delayed adjuvant therapy initiation, and impaired long-term nutritional recovery and quality of life.
Braun anastomosis (BE) can reconstruct the gastrointestinal tract by side-to-side jejunojejunostomy between the afferent and efferent limbs, which may reduce intestinal stasis, bile reflux and afferent limb obstruction, and theoretically lower the risk of postoperative DGE. However, current clinical studies and meta-analyses remain controversial regarding the actual efficacy of BE in preventing DGE after PD. Some studies support that BE can reduce DGE incidence, shorten hospitalization and improve postoperative recovery, while others demonstrate no statistically significant benefit, or even concern about prolonged operative time and technical difficulty. Existing evidence is limited by small sample size, retrospective design and potential selection bias, and high-quality prospective randomized controlled trials are still lacking to confirm the clinical value of BE.
This study is designed as a prospective, single-center, randomized controlled trial, aiming to evaluate the impact of routine Braun anastomosis during digestive tract reconstruction on the incidence and severity of postoperative DGE in patients undergoing pancreaticoduodenectomy for malignant tumors. The results will provide high-level clinical evidence for the rational application of Braun anastomosis in PD reconstruction and guide standardized clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Braun arm | Experimental | Procedure: Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomyPD with Billroth II reconstruction plus Braun anastomosis |
| Non Braun Arm | Other | Procedure: Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.PD with Billroth II reconstruction alone (without Braun anastomosis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years, male or female;
- Scheduled to undergo curative pancreaticoduodenectomy (PD);
- Undergoing PD for malignant or borderline tumors, with planned antecolic Billroth II reconstruction;
- Mentally competent and able to provide written informed consent.
Key exclusion criteria (10 listed)
- Age < 18 years;
- Prior diagnosis of gastroparesis;
- Benign disease as the indication for PD;
- Previous history of upper gastrointestinal surgery;
- Preoperative pyloric obstruction;
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 |
|---|---|---|
| Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomyIntervention Group: Patients undergo PD with antecolic Billroth II reconstruction plus Braun enteroenterostomy (BE). | Procedure or surgery | Braun arm |
| Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy. | Procedure or surgery | Non Braun Arm |
Primary outcome
Incidence of delayed gastric emptying (DGE)
Time frame: Postoperative days 1, 8, 15, and 22
Incidence of delayed gastric emptying (DGE), defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria
6 secondary outcomes
Length of hospital stay (days)
Time frame: From first postoperative day to hospital discharge up to 15 weeks
Treatment cost
Time frame: From the first postoperative day to one year follow-up
Postoperative recovery
Time frame: From the first postoperative day to one year follow-up
Bile reflux
Time frame: Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.
Proportion of severe complications as defined by the Clavien-Dindo classification
Time frame: From the first postoperative day to one year follow-up
Quality of life scores assessed using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire at 30 days postoperatively
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy and Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy. in people with Periampullary Carcinoma Resectable, run by Tianjin Medical University Cancer Institute and Hospital 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunlong Cui, PhD (+86 18622228633, ningyunlong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delayed gastric emptying (DGE) (time frame: Postoperative days 1, 8, 15, and 22). 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 2 Jul 2026.