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2025-07-20
2027-07-20
2028-07-20
20
NCT07087392
West China Hospital
West China Hospital
INTERVENTIONAL
Inverted-Ω Anastomosis in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy
The goal of this clinical trial is to learn if inverted-Ω anastomosis after pancreatic head resection or mid-pancreatectomy works in benign or low-grade malignant tumor. It will also learn about the safety and feasibility of inverted-Ω anastomosis. The main questions it aims to answer are: 1. Does inverted-Ω anastomosis operate safely? (operative time, blood loss, transfusion and conversion rate) 2. What is the incidence and severity of postoperative complications in inverted -Ω anastomosis? What advantages does it have over conventional anastomosis methods such as roux-en-y？
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-07-08 | N/A | 2025-07-24 |
2025-07-24 | N/A | 2025-07-28 |
2025-07-28 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Inverted-Ω Anastomosis After meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tr | PROCEDURE: Inverted-Ω Anastomosis
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Safety and assessment of the surgical process | The incidence of intraoperative adverse events such as conversion to open surgery rate | During operation |
| Operative time | Operative time | During operation |
| Intraoperative blood loss | Intraoperative blood loss | During operation |
| Postoperative complications | The incidence and severity of postoperative complications, as defined by the International Study Group on Pancreatic Surgery (ISGPS) | From the date of surgery (Day 0) up to 90 days postoperatively |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Short-term survival | From the date of surgery (Day 0) up to 3 years postoperatively |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Zhong Wu Phone Number: +86 189 8060 6518 Email: wuzhong0057@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
