Open Versus Laparoscopic Assisted Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-12-01

Brief Summary

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Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

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Detailed Description

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Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. \[1\]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers\[2,3\]. In recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers \[4,5\]. Laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy\[6\]. Several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy\[7,8\]. Limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .Also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.So the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.

Conditions

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Pancreas Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Laparoscopic assisted pancreaticoduodenctomy

If inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy.

Group Type EXPERIMENTAL

laparoscopic assisted pancreaticoduodenectomy

Intervention Type PROCEDURE

laparoscopic assisted pancreaticoduodenectomy.

Open pancreaticduodenctomy

criteria are met ,these group of patients will undergo open pancreaticoduodenctomy

Group Type ACTIVE_COMPARATOR

Open pancreaticduodenctomy

Intervention Type PROCEDURE

Open pancreaticduodenctomy

Interventions

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laparoscopic assisted pancreaticoduodenectomy

laparoscopic assisted pancreaticoduodenectomy.

Intervention Type PROCEDURE

Open pancreaticduodenctomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. age less than 70 years.
2. resectable tumour,
3. fit for surgery

Exclusion Criteria

1. patients with jaundice with serum bilirubin above 200mml/dl.
2. patients with bleeding tendency until corrected.
3. patients with advanced and metastatic malignancy.
4. patients with cardiopulmonary diseases.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No