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Modified vs Conventional Blumgart Anastomosis of LPD for the Effects of Pancreatic Fistula of Periampullary Carcinoma

Primary Purpose

Ampullary Cancer, Bile Duct Cancer, Pancreas Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified Blumgart Anastomosis in LPD
conventional Blumgart anastomosis in LPD
Sponsored by
Affiliated Hospital of Guangdong Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ampullary Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Diagnosis of malignant tumors in other sites; ASA grade IV and / or ECOG physical strength status score> 2 points; Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or severe basic diseases who cannot tolerate surgery; Have an uncontrolled preoperative infection; Pregnant or lactating women; A history of serious mental illness; Patients with other clinical and laboratory conditions considered by the investigator are not suitable to participate in this trial

Sites / Locations

  • The Affiliated Hospital of Guangdong Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Modified Blumgart Anastomosis of LPD

Conventional Blumgart Anastomosis of LPD

Arm Description

The effect of modified Blumgart technique in the treatment of periampulltrary carcinoma on postoperative pancreatic fistula

The effect of Conventional Blumgart Anastomosis in the treatment of periampulltrary carcinoma on postoperative pancreatic fistula

Outcomes

Primary Outcome Measures

The rate of POPF
The rate of Postoperative pancreatic fistula

Secondary Outcome Measures

Full Information

First Posted
August 30, 2023
Last Updated
October 7, 2023
Sponsor
Affiliated Hospital of Guangdong Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06076252
Brief Title
Modified vs Conventional Blumgart Anastomosis of LPD for the Effects of Pancreatic Fistula of Periampullary Carcinoma
Official Title
Modified Blumgart vs Conventional Blumgart Anastomosis Technique in the Treatment of Periampulltrary Carcinoma on Postoperative Pancreatic Fistula: an Open, Randomized, Parallel Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 1, 2028 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Guangdong Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
This study intends to use a prospective randomized controlled trial, the LPD patients with traditional Blumgart anastomosis as the control group, design the LPD patients with modified Blumgart anastomosis as the test group, by comparing the clinical correlation index and the rate of postoperative complications in LPD can truly simplify the surgical procedure and ensure the lower rate of pancreatic leakage. The following steps will be followed: Patients who met the inclusion criteria and did not meet the exclusion criteria underwent modified Blumgart anastomosis according to the randomization LPD surgery group (test group) or LPD surgery group with conventional Blumgart pancreatecreenterostomy (control group). The following common LPD procedure was used in the test and control groups: ① Preoperative preparation and anesthesia mode Preoperative gastric tube, urinary tube and central venous channel; general anesthesia ② Same surgical procedure: Establishment of artificial pneumoperitoneum and operating hole anatomical exploratory specimen resection and reconstruction of digestive tract (biliary intestine kiss Combination, gastrointestinal anastomosis) drain placement. In the test group, the pancreatic intestine anastomosis in the LPD Combined, the control group used conventional Blumgart pancreatestatic anastomosis. Both postoperative groups were routinely given anti-infection, gastric mucosa protection, somatostatin, and nutritional supportive therapy. After the first Remove gastric tube and urinary catheter on 3 days, instructed patients to eat cold liquid food and ambulation; somatostatin was stopped on postoperative day 5, The upper abdominal CTA was reviewed, and the remaining treatment plans were formulated according to the actual situation of the patient. Postoperative numbers 1,3,5, and For 7 days, the relevant drainage indexes, daily drainage rate, drainage properties and amylase content were reviewed. If the patient can be discharged with the following conditions: the general condition is good, and the normal diet and intestinal function are basically restored; Body temperature was normal and the abdominal examination showed no positive signs; relevant laboratory results were almost normal; CTA Significant abdominal effusion and other abnormalities; postoperative abdominal incision healed well. After discharge, pay attention to their appetite, spirit, urine and feces, and drainage tube (discharged with drainage tube). Patients without special discomfort were returned to the hospital for review once at 1and 3 months after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ampullary Cancer, Bile Duct Cancer, Pancreas Cancer, Duodenum Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Blumgart Anastomosis of LPD
Arm Type
Experimental
Arm Description
The effect of modified Blumgart technique in the treatment of periampulltrary carcinoma on postoperative pancreatic fistula
Arm Title
Conventional Blumgart Anastomosis of LPD
Arm Type
Other
Arm Description
The effect of Conventional Blumgart Anastomosis in the treatment of periampulltrary carcinoma on postoperative pancreatic fistula
Intervention Type
Procedure
Intervention Name(s)
Modified Blumgart Anastomosis in LPD
Intervention Description
This study is a clinical study designed by parallel control, the test group is LPD patients with modified Blumgart anastomosis and the control group is LPD patients with conventional Blumgart anastomosis
Intervention Type
Procedure
Intervention Name(s)
conventional Blumgart anastomosis in LPD
Intervention Description
This study is a clinical study designed by parallel control, the test group is LPD patients with modified Blumgart anastomosis and the control group is LPD patients with conventional Blumgart anastomosis
Primary Outcome Measure Information:
Title
The rate of POPF
Description
The rate of Postoperative pancreatic fistula
Time Frame
90 Days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Diagnosis of malignant tumors in other sites; ASA grade IV and / or ECOG physical strength status score> 2 points; Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or severe basic diseases who cannot tolerate surgery; Have an uncontrolled preoperative infection; Pregnant or lactating women; A history of serious mental illness; Patients with other clinical and laboratory conditions considered by the investigator are not suitable to participate in this trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Guohua
Organizational Affiliation
Affiliated Hospital of Guangdong Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The Affiliated Hospital of Guangdong Medical University
City
Zhanjiang
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Modified vs Conventional Blumgart Anastomosis of LPD for the Effects of Pancreatic Fistula of Periampullary Carcinoma

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