The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy

NCT07681128 | Recruiting

• 1 other identifier: Braun-HCC
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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%. 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

Keywords

Pancreaticoduodenectomy; Braun Anastomosis; Delayed Gastric Emptying

Outcome Measures

Primary Outcomes (1)

• Incidence of delayed gastric emptying (DGE)

  Incidence of delayed gastric emptying (DGE), defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria

  Postoperative days 1, 8, 15, and 22

Secondary Outcomes (6)

• Length of hospital stay (days)

  From first postoperative day to hospital discharge up to 15 weeks

• Treatment cost

  From the first postoperative day to one year follow-up

• Postoperative recovery

  From the first postoperative day to one year follow-up

• Bile reflux

  Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.

• Proportion of severe complications as defined by the Clavien-Dindo classification

  From the first postoperative day to one year follow-up

Study Arms (2)

Braun arm

EXPERIMENTAL

PD with Billroth II reconstruction plus Braun anastomosis

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)

Procedure: Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.

Interventions

Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy PROCEDURE

Intervention Group: Patients undergo PD with antecolic Billroth II reconstruction plus Braun enteroenterostomy (BE).

Braun arm

Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy. PROCEDURE

Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.

Non Braun Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yunlong Cui, PhD

CONTACT

+86 18622228633; ningyunlong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: July 2, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)