NCT06076252Enrolling by invitation
Modified vs Conventional Blumgart Anastomosis of LPD for the Effects of Pancreatic Fistula of Periampullary Carcinoma
Modified Blumgart vs Conventional Blumgart Anastomosis Technique in the Treatment of Periampulltrary Carcinoma on Postoperative Pancreatic Fistula: an Open, Randomized, Parallel Controlled Clinical Study
Source: ClinicalTrials.gov · Last updated 10 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The incidence rate and mortality rate of periampullary cancer at home and abroad both show an increasing trend, seriously affecting the health level of the people. Pancrecoduodenectomy (PD) is the only effective treatment for periampullary cancer. However, due to the complex technology and difficulty of PD surgery, laparoscopic pancreaticoduodenectomy (LPD) is more difficult, and the postoperative mortality can reach 5%. The important reason is the most serious complication- -pancreatic fistula. The occurrence of pancreatic fistula is related to many factors, and the most critical factor is the method and technology of pancreatico-intestinal anastomosis, so the improvement and innovation of pancreaticoco-intestinal anastomosis technology has always been a hot topic in surgical clinical research. Blumgart Pancreatic anastomosis was originally created by Professor L.H.Blumgart in the United States, and was widely used in OPD due to its low incidence of pancreatic fistula. However, the traditional Blumgart anastomosis is complicated and is not suitable for application in LPD. According to our own experience, our team simplified and improved the traditional Blumgart anastomosis to OPD, and through retrospective study, it has the advantages of reducing the incidence of pancreatic fistula. However, the application value in LPD still needs to be further discussed. Therefore, this study intends to use a prospective randomized controlled trial, using the LPD patients with traditional Blumgart pancreatecointestinal anastomosis as the control group, and the LPD patients with modified Blumgart pancreatecointestinal anastomosis as the test group, compare the clinical relevant indicators and the incidence of postoperative complications, and explore whether the application value in LPD can truly simplify the surgical procedure and ensure the lower incidence of pancreatic leakage.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 30 Aug 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Affiliated Hospital of Guangdong Medical University
- NCT number
- NCT06076252
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Jul 2023 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of malignant tumors in other sites;
- Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or severe basic diseases who cannot tolerate surgery;
- Have an uncontrolled preoperative infection;
- A history of serious mental illness;
Lab values
- Patients with other clinical and laboratory conditions considered by the investigator are not suitable to participate in this trial
Other
- ASA grade IV and / or ECOG physical strength status score\> 2 points;
- Pregnant or lactating women;
Who the study is looking for
- Radically resectable stage I - III low periampullary carcinoma in patients, And all met the following criteria:
- age 18-75 years;
- imaging (upper abdominal MRI, MRCP / CT / CTA) diagnosis of periampullary (duodenal papilla, ampulla, inferior common bile duct, pancreatic head);
- MDT discussion of tumor invasion of large vessels (SMA, CA, CHA/SMV, PV) resectable;
- endoscopic duodenal ultrasound diagnosis of periampullary carcinoma;
- endoscopic biopsy pathology confirmation of carcinoma (not essential);
- preoperative stage within T3N1;
- no evidence of distant metastasis;
- cardiopulmonary and liver and kidney function can tolerate surgery;
- patients and family members can understand and willing to participate in this study, Provided the written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Guangdong Medical University Coordinator of this site? Confirm its status | Zhanjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.